About Over The Counter (OTC) medicine

The following information is provided pursuant to Article 147-7 of the Enforcement Regulations of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.

Matters Concerning the Management and Operation of the Store Sales Business

【License Category】

Store Sales Business

【Store Sales Business Operator】

iEntEmerge Inc.

【License Number】

Funabashi Health Center No. 0167 (Store Sales Business)

【License Validity Period】

April 1, 2024 - March 31, 2030

【Store Name】

TFO Drugstore

【Location】

Room 301, Nakanogi Mitsuru Building No. 2, 4-19-26 Higashi-Funabashi, Funabashi City, Chiba Prefecture

【Competent Authority】

Funabashi City Health Center (Store Sales Business)

【Store Manager】

Pharmacist Yuki Yamamoto

【Pharmacists and Registered Sellers Working at the Store, Names, and Duties】

Pharmacist Yuki Yamamoto (Duties: store management, sales, information provision, and consultation)

【Pharmacists and Registered Sellers Currently on Duty】

Pharmacist Yuki Yamamoto (weekdays 10:00-16:00)

【Categories of OTC Medicines Handled】

Designated Class 2 OTC Medicines, Class 2 OTC Medicines, and Class 3 OTC Medicines

* If any medicine falls under the category of Designated Misuse Prevention Medicines, the necessary confirmation, information provision, and sales restrictions will be carried out in accordance with applicable laws and regulations.

【Explanation of Classification by Name Tags, etc.】

Pharmacists wear a white coat and a name tag indicating “Pharmacist” and their name.

Registered sellers wear a white coat and a name tag indicating “Registered Seller” and their name.

General staff members wear clothing other than the above.

【Business Hours】

Weekdays 10:00-16:00

【Physical Store Opening Hours】

Weekdays 10:00-16:00

【Hours for Specified Sales】

Weekdays 10:00-16:00

【Hours for Consultation with a Specialist】

Weekdays 10:00-16:00

【Consultation Hours Outside Business Hours】

None

【Order Acceptance Hours】

24 hours a day, 7 days a week

【Contact Information for Consultation and Emergencies】

Phone: 090-6920-9274

(Japanese only)

Email: taxfreeonline_support@ient.co.jp

【Photos of the Store and Photos Showing the Display Status】

 

 

Matters Concerning the System for the Sale of Guidance-Mandatory Medicines and OTC Medicines (Definitions and Explanations)

【Guidance-Mandatory Medicines】

・Medicines for which the risks have not yet been established as OTC medicines

・Medicines with strong toxicity or potency

【OTC Medicines】

OTC medicines are classified into Classes 1 to 3 according to risk.

【Class 1 OTC Medicines】

・Medicines with particularly high risk

・Medicines that may cause side effects and require special attention

【Class 2 OTC Medicines】

・Medicines with relatively high risk

・Medicines that may, in rare cases, cause side effects

【Designated Class 2 OTC Medicines】

Medicines among Class 2 OTC Medicines that contain ingredients requiring special attention.

【Class 3 OTC Medicines】

・Medicines with relatively low risk

・Medicines that may cause physical changes or discomfort

【Designated Misuse Prevention Medicines】

Designated Misuse Prevention Medicines are medicines designated by the Minister of Health, Labour and Welfare as medicines that may cause central nervous system excitation, depression, or hallucinations if misused, and for which misuse prevention measures are necessary.

The relevant ingredients are ephedrine, codeine, dihydrocodeine, diphenhydramine, dextromethorphan, pseudoephedrine, bromovalerylurea, methylephedrine, and their hydrates or salts.

However, external preparations and preparations whose main active ingredients are crude drugs are excluded.

 

Explanation of Labeling for Guidance-Mandatory Medicines and OTC Medicines

The risk classification is indicated on the medicine package, such as the outer box or outer packaging, and in the package insert. Labeling methods include printed labeling and sticker labeling.

1) Guidance-Mandatory Medicines are labeled as Guidance-Mandatory Medicines.

2) Class 1 OTC Medicines are labeled as Class 1 OTC Medicines.

3) Designated Class 2 OTC Medicines are labeled by enclosing the number “2” in a frame, or by displaying them as Designated Class 2 OTC Medicines.

4) Class 2 OTC Medicines are labeled as Class 2 OTC Medicines.

5) Class 3 OTC Medicines are labeled as Class 3 OTC Medicines.

6) Designated Misuse Prevention Medicines are labeled with “Confirmation Required” or similar wording.

For Designated Misuse Prevention Medicines, “Confirmation Required” or similar wording is indicated on the immediate container or immediate packaging of the product.

For Designated Misuse Prevention Medicines at or below the quantity specified by the Minister of Health, Labour and Welfare, the wording “Confirmation Required” is displayed within a square frame.

For Designated Misuse Prevention Medicines exceeding the quantity specified by the Minister of Health, Labour and Welfare, wording in which the word “Required” in “Confirmation Required” is enclosed in a circle or square is displayed within a square frame.

If the labeling on the immediate container or immediate packaging cannot be seen from the outside, the same labeling is also indicated on the outer container or outer packaging.

 

Explanation of Information Provision and Guidance for Guidance-Mandatory Medicines and OTC Medicines

1) Guidance-Mandatory Medicines

At the information provision area, a pharmacist provides information to the user in person using a confirmation tool and written documents. At the pharmacist’s discretion, guidance such as recommending another medicine or advising medical consultation may be provided.

 

2) Class 1 OTC Medicines

A pharmacist provides information using a confirmation tool and written documents. At the pharmacist’s discretion, guidance such as advising medical consultation may be provided.

 

3) Designated Class 2 OTC Medicines

Pharmacists and registered sellers actively endeavor to provide information.

4) Class 2 OTC Medicines

Pharmacists and registered sellers endeavor to provide information as required by law.

5) Class 3 OTC Medicines

Pharmacists and registered sellers endeavor to provide information as necessary.

6) Designated Misuse Prevention Medicines

When selling Designated Misuse Prevention Medicines, a pharmacist or registered seller provides information in writing or by other appropriate means, including that misuse of the medicine may cause health and hygiene hazards.

In addition, information required according to the category of OTC medicine is provided, and the customer’s understanding of the information and whether the customer has any questions are confirmed.

At the time of sale, a pharmacist or registered seller confirms matters necessary to determine that the purchase is for proper use, including the customer’s age, the use status of other drugs or medicines, and the purchase or receipt status of Designated Misuse Prevention Medicines.

For customers under 18 years of age, the customer’s name will also be confirmed. If the customer intends to purchase a quantity exceeding the quantity specified by the Minister of Health, Labour and Welfare, or intends to purchase multiple units, the reason for the purchase will be confirmed.

If the necessary confirmation or information provision cannot be completed, or if a pharmacist or registered seller determines that there is a possibility that the Designated Misuse Prevention Medicine may not be used properly, the sale may be refused, and the order may be canceled or shipment may be suspended.

 

Explanation of Website Display for Designated Class 2 OTC Medicines, Confirmation of Contraindications, and Recommendation to Consult a Specialist

For Designated Class 2 OTC Medicines, we provide website display that encourages customers to check contraindications. We also indicate that customers are recommended to consult a pharmacist or registered seller regarding the use of the relevant Designated Class 2 OTC Medicines.

 

Explanation of Website Display for Designated Misuse Prevention Medicines and Recommendation to Consult a Specialist

For Designated Misuse Prevention Medicines, we display that misuse of the relevant medicine may cause health and hygiene hazards.

We also indicate that customers are recommended to consult a pharmacist or registered seller regarding the use of Designated Misuse Prevention Medicines.

 

Explanation of Sales Methods for Designated Misuse Prevention Medicines

When selling Designated Misuse Prevention Medicines to customers under 18 years of age, or when selling a quantity exceeding the quantity specified by the Minister of Health, Labour and Welfare, the necessary information provision and confirmation will be carried out in accordance with applicable laws and regulations, either face-to-face or through real-time two-way communication using video and audio.

However, Designated Misuse Prevention Medicines exceeding the quantity specified by the Minister of Health, Labour and Welfare, or multiple units of Designated Misuse Prevention Medicines, cannot be sold to customers under 18 years of age.

 

Explanation of Website Display for OTC Medicines

OTC medicines are displayed by therapeutic category and risk category.

 

Explanation of Display of Designated Class 2 OTC Medicines

Designated Class 2 OTC Medicines are displayed within 7 meters of the equipment used to provide information.

 

Explanation of Display of Designated Misuse Prevention Medicines

When displaying Designated Misuse Prevention Medicines, in addition to the display method according to the category of the medicine, they are displayed in equipment that customers cannot directly access, in locked display equipment, or within 7 meters of the information provision equipment and within the visible range of a pharmacist or registered seller.

The actual medicines are managed in a place where customers cannot directly access them.

 

Explanation of Display of Guidance-Mandatory Medicines and OTC Medicines

Medicines classified by risk are displayed separately according to risk category. If no specialist is present, the medicine sales area will be closed, and medicines cannot be sold while it is closed.

* OTC medicines handled at the physical store: Designated Class 2 OTC Medicines, Class 2 OTC Medicines, and Class 3 OTC Medicines

【Display by Risk Category】

Medicines are displayed together by risk category so that different risk categories are not mixed, even within the same therapeutic group.

【Display of Guidance-Mandatory Medicines and Class 1 OTC Medicines】

These medicines are displayed in a place where customers cannot directly access them, so that customers can purchase them after receiving information directly from a pharmacist in person.

【Display of Designated Class 2 OTC Medicines, Class 2 OTC Medicines, and Class 3 OTC Medicines】

Class 2 OTC Medicines and Class 3 OTC Medicines are displayed separately.

 

Explanation of Expiration Dates of OTC Medicines

We ship medicines with at least 100 days remaining before the expiration date.

 

Explanation of the Relief System for Health Damage Caused by Medicines

【Relief System for Adverse Drug Reactions】

If a person suffers health damage despite using a medicine properly, the person may be eligible for the Relief System for Adverse Drug Reactions. Some medicines and adverse reactions are not covered by the relief system.

 

【Consultation Desk】

Phone: 0120-149-931

Reception hours: 9:00 a.m. to 5:00 p.m. (Monday to Friday, excluding national holidays and year-end/New Year holidays)

 

Measures When There Is a Possibility That Medicines May Not Be Used Properly

If, based on the customer’s purchase status or other circumstances, a pharmacist or registered seller determines that there is a possibility that the medicines may not be used properly, we may cancel the order or suspend shipment.

For Designated Misuse Prevention Medicines, if the necessary confirmation or information provision is not completed, or if we cannot confirm that the purchase is for proper use, we may also cancel the order or suspend shipment.

 

Measures to Ensure Proper Handling of Personal Information

Personal information will be handled appropriately in accordance with this website’s Privacy Policy.