Label: AQUAFRESH KIDS CAVITY PROTECTION- sodium monofluorophosphate paste

  • 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 November 9, 2020

If you are a consumer or patient please visit this version.

  • 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
  • INGREDIENTS AND APPEARANCE
    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)