SPL v2
SPL
SPL Set ID 32b8bbfd-097a-dae4-e063-6294a90ac0d6
Route
TOPICAL
Published
Effective Date 2025-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mentha X Piperita Whole (19.286 mg)
Inactive Ingredients
Aqua Glycerin 1,2-hexanediol Thiamine Gluconolactone Allantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-14

Description

MENTHA X PIPERITA WHOLE


Medication Information

Warnings and Precautions

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

Description

MENTHA X PIPERITA WHOLE

Section 44425-7

Store in a cool and dry place.

Section 50565-1

Please keep out of reach of children. Do not swallow.

Section 50566-9

Discontinue use if signs of irritation or rash occur.

Section 50567-7

Spray directly on the mouth (toothache) For discomfort, 1-3 sprays each time, 2-3 times a day or as needed.

Section 50570-1

Discontinue use if signs of irritation or rash occur.

Section 51727-6

AQUA、GLYCERIN、GLUCONOLACTONE、1,2-HEXANEDIOL、VITAMIN B1、ALLANTOIN

Section 51945-4

Section 55105-1

Suitable for daily cleaning and long-lasting oral maintenance of oral discomfort caused by Staphylococcus aureus.

Section 55106-9

MENTHA X PIPERITA WHOLE


Structured Label Content

Warnings and Precautions (34071-1)

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

Section 44425-7 (44425-7)

Store in a cool and dry place.

Section 50565-1 (50565-1)

Please keep out of reach of children. Do not swallow.

Section 50566-9 (50566-9)

Discontinue use if signs of irritation or rash occur.

Section 50567-7 (50567-7)

Spray directly on the mouth (toothache) For discomfort, 1-3 sprays each time, 2-3 times a day or as needed.

Section 50570-1 (50570-1)

Discontinue use if signs of irritation or rash occur.

Section 51727-6 (51727-6)

AQUA、GLYCERIN、GLUCONOLACTONE、1,2-HEXANEDIOL、VITAMIN B1、ALLANTOIN

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Suitable for daily cleaning and long-lasting oral maintenance of oral discomfort caused by Staphylococcus aureus.

Section 55106-9 (55106-9)

MENTHA X PIPERITA WHOLE


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)