AN TOOTH- sodium monofluorophosphate paste, dentifrice

AN TOOTH by

Drug Labeling and Warnings

AN TOOTH by is a Otc medication manufactured, distributed, or labeled by AN Co Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Sodium Monofluorophosphate 0.01%

INACTIVE INGREDIENT

Inactive ingredients: Precipitated Calcium Carbonate, D-Sorbitol Solution, Glycerin, Sodium Lauryl Sulfate, Polyethylene Glycol 1500, Carboxymethylcellulose Sodium, Mentha Oil, l-Menthol, Methyl ρ-Hydroxybenzoate, Steviol Glycoside, Aminocaproic Acid, Xylitol, Aluminum Chlorohydroxy Allantoinate, Dibasic Calcium Phosphate Hydrat, Chitosan, Propolis Extract, Argentum, FD&C Blue No.1, Deionized Water

PURPOSE

Purpose: Anticaries

WARNINGS

Warnings: 1. Try not to swallow toothpaste, gargle enough with water. 2. If a problem arises as these toothpaste, consult to dentist or physician after stop the using. 3. If use a children under six years of age, just use like pea-sized amount and supervise child’s brushing and rinsing. 4. If swallowed the toothpaste a children under six years of age, immediately consult with dentist or physician. 5. Keep this product out of the reach of children under six years of age.

KEEP OUT OF REACH OF CHILDREN

Keep this product out of the reach of children under six years of age.

Directions

Directions: Brush teeth with balance of toothpaste.

Directions

Directions: Brush teeth with balance of toothpaste.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AN TOOTH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69153-120
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.016 g  in 160 g

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Polyethylene Glycol 1500 (UNII: 1212Z7S33A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69153-120-02	1 in 1 CARTON	02/01/2017
1	NDC: 69153-120-01	160 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/01/2017

Labeler - AN Co Ltd. (688448454)

Registrant - AN Co Ltd. (688448454)

Establishment
Name	Address	ID/FEI	Business Operations
AN Co Ltd.		688448454	manufacture(69153-120)