Kids Kare - Dye Free Gel

STANNOUS FLUORIDE - stannous fluoride gel 
Zila Therapeutics, Inc.

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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Kids Kare - Dye Free Gel

DRUG FACTS

OTC - ACTIVE INGREDIENT

Stannous fluoride 0.4% w/w (0.13% w/v fluoride ion)

Contains 0.4% Stannous Fluoride in a Stable, Water Free Gel

OTC - PURPOSE

Anticavity

INDICATIONS AND USAGE

USES

  • Aids in prevention of dental caries (cavities).
  • The combined daily use of a fluoride preventive treatment gel and a fluoride toothpaste can help reduce the incidence of dental cavities.

OTC - KEEP OUT OF REACH OF CHILDREN

  • PLEASE KEEP OUT OF REACH OF CHILDREN.

WARNINGS

  • If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
  • Use only under guidance or supervision of a dentist.

DOSAGE AND ADMINISTRATION

DIRECTIONS:

Adults and Children
6 Years and Older
                                           
This is a fluoride preventive treatment gel, not a toothpaste. Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing.
Children 6 to 12
                                                   
Instruct and supervise brushing and rinsing (to minimize swallowing) until good brushing habits are established.
Children Under 6
                                                    
Ask a dentist or doctor.

OTHER INFORMATION:

This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dental professional.

INACTIVE INGREDIENT

Natural flavor, glycerin and hydroxyethyl cellulose

Made for and Distributed in US by: Zila Therapeutics, Inc.,

P.O. Box 3889, Batesville, AR 72503

1-800-228-5595

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

161ffc6c-figure-01
STANNOUS FLUORIDE 
stannous fluoride gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59883-643
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION) FLUORIDE ION1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59883-643-04122 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/21/200802/15/2013
Labeler - Zila Therapeutics, Inc. (883514127)
Establishment
NameAddressID/FEIBusiness Operations
Zila Therapeutics, Inc.883514127MANUFACTURE(59883-643)

Revised: 1/2014
 
Zila Therapeutics, Inc.