Label: AQUAFRESH KIDS CAVITY PROTECTION- sodium monofluorophosphate paste
- NDC Code(s): 0135-0619-01
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- 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 10, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
- •
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adults and children 2 years and older:
- o
- apply toothpaste onto a toothbrush.
- o
- brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
- o
- to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.
- •
- children under 2 years of age: Consult a dentist or doctor.
- Other information
- Inactive ingredients (bubble mint)
- Questions or comments?
-
Principal Display Panel
NDC 0135-0619-01
Aquafresh®
Fluoride Toothpaste
kids
Cavity Protection
2+ years
Sugar Acid Protection **
From Fluoride
BUBBLE MINT
ADA Accepted
American Dental Association®
NET WT 4.6 OZ (130.4 g)
Aquafresh toothpaste fights cavities with fluoride...
freshens breath...
and has a great bubble mint taste, in one complete toothpaste.
**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.
ALWAYS FOLLOW THE LABEL
This product contains no sugar, like all ADA-accepted toothpastes.
Helps prevent cavities.
Note: If pump doesn't work, hold button down and firmly push up inside base.
Trademarks are owned by or licensed to the GSK group of companies.
Distributed by:
GSK Consumer Healthcare
Warren, NJ 07059
©2015 GSK or its licensor
105855XB
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INGREDIENTS AND APPEARANCE
AQUAFRESH KIDS CAVITY PROTECTION
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0619 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.10 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) CALCIUM CARBONATE (UNII: H0G9379FGK) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CARRAGEENAN CALCIUM (UNII: 5C4SQ0541D) D&C RED NO. 30 (UNII: 2S42T2808B) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0619-01 130.4 g in 1 CANISTER; Type 0: Not a Combination Product 09/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 09/01/2017 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
