Label: AQUAWHITE BLUE GEL CAVITY FIGHTINGTOOTH- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 72025-002-01, 72025-002-02 - Packager: JHS SVENDGAARD LABORATORIES LIMITED
- 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 January 16, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions:
- Adults and children 2 years and older:
- Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
- Do not swallow
- Children under 6 Years of Age
- To minimize swallowing use a pea-sized amount and supervise children's brushing untill good habits are established.
Children under 2 years of age:
- Ask a dentist or physician
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AQUAWHITE BLUE GEL CAVITY FIGHTINGTOOTH
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72025-002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE (UNII: SE337SVY37) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) XANTHAN GUM (UNII: TTV12P4NEE) MENTHOL (UNII: L7T10EIP3A) SACCHARIN SODIUM (UNII: SB8ZUX40TY) XYLITOL (UNII: VCQ006KQ1E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72025-002-01 80 g in 1 TUBE; Type 0: Not a Combination Product 01/16/2018 2 NDC:72025-002-02 150 g in 1 TUBE; Type 0: Not a Combination Product 01/16/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/16/2018 Labeler - JHS SVENDGAARD LABORATORIES LIMITED (675939900) Establishment Name Address ID/FEI Business Operations JHS SVENDGAARD LABORATORIES LIMITED 675939900 manufacture(72025-002)
