Label: AN TOOTH- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 69153-120-01, 69153-120-02 - Packager: AN Co Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 27, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
- Directions
- Directions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AN TOOTH
sodium monofluorophosphate paste, dentifriceProduct 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)
