AQUAFRESH KIDS CAVITY PROTECTION- sodium monofluorophosphate paste 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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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Drug Facts

Active ingredient

Sodium monofluorophosphate 0.84% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities.

Warnings

When using this product,

if irritation occurs discontinue use.

Keep out of the reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years and older:
apply toothpaste onto a toothbrush.
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.
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

Do not store above 25°C (77°F)

Inactive ingredients (bubble mint)

water, sorbitol, calcium carbonate, hydrated silica, glycerin, PEG-8, flavor, titanium dioxide, sodium lauryl sulfate, cellulose gum, sodium bicarbonate, sodium saccharin, calcium carrageenan, red 30, blue 1

Questions or comments?

Call toll-free 1-800-897-5623

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

105855XB_Aquafresh Kids_4.6 oz.JPG
AQUAFRESH  KIDS CAVITY PROTECTION
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0619
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 FORM (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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0619-01130.4 g in 1 CANISTER; Type 0: Not a Combination Product09/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/01/2017
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 11/2020
Document Id: bfd08a48-c926-4126-90fb-4a3527ebb678
Set id: 6ec04957-df13-498a-83a4-62dc6d212137
Version: 2
Effective Time: 20201109
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC