SOUTH MOON TOOTHACHE- glycerin liquid

SOUTH MOON Toothache by

Drug Labeling and Warnings

SOUTH MOON Toothache by is a Otc medication manufactured, distributed, or labeled by Shantou South Moon Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

MENTHA X PIPERITA WHOLE

WHEN USING

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

PURPOSE

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

DO NOT USE

Discontinue use if signs of irritation or rash occur.

STOP USE

Discontinue use if signs of irritation or rash occur.

KEEP OUT OF REACH OF CHILDREN

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

WARNINGS

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.

STORAGE AND HANDLING

Store in a cool and dry place.

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

INDICATIONS & USAGE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOUTH MOON TOOTHACHE 
glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84983-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHA X PIPERITA WHOLE (UNII: 79M2M2UDA9) (MENTHA X PIPERITA WHOLE - UNII:79M2M2UDA9)	MENTHA X PIPERITA WHOLE	0.06 mg  in 20 mg

Inactive Ingredients
Ingredient Name	Strength
AQUA (UNII: 059QF0KO0R)	19.286 mg  in 20 mg
GLYCERIN (UNII: PDC6A3C0OX)	0.6 mg  in 20 mg
ALLANTOIN (UNII: 344S277G0Z)	0.004 mg  in 20 mg
1,2-HEXANEDIOL (UNII: TR046Y3K1G)	0.02 mg  in 20 mg
THIAMINE (UNII: X66NSO3N35)	0.01 mg  in 20 mg
GLUCONOLACTONE (UNII: WQ29KQ9POT)	0.02 mg  in 20 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84983-005-01	20 mg in 1 BOX; Type 0: Not a Combination Product	04/14/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	04/14/2025

Labeler - Shantou South Moon Biotechnology Co., Ltd. (457126192)

Registrant - Shantou South Moon Biotechnology Co., Ltd. (457126192)

Establishment
Name	Address	ID/FEI	Business Operations
Shantou South Moon Biotechnology Co., Ltd.		457126192	manufacture(84983-005)