AN TOOTH- sodium monofluorophosphate paste, dentifrice 
AN Co Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Image of carton

AN TOOTH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69153-120
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.016 g  in 160 g
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Polyethylene Glycol 1500 (UNII: 1212Z7S33A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69153-120-021 in 1 CARTON02/01/2017
1NDC:69153-120-01160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/01/2017
Labeler - AN Co Ltd. (688448454)
Registrant - AN Co Ltd. (688448454)
Establishment
NameAddressID/FEIBusiness Operations
AN Co Ltd.688448454manufacture(69153-120)

Revised: 2/2017
Document Id: 1240e625-d815-47c2-8c98-8fa297fa609b
Set id: 0989102a-cf0c-4ddb-9f0e-5b2c85c93ddd
Version: 1
Effective Time: 20170227
 
AN Co Ltd.