KIDS KARE- stannous fluoride gel

kids kare by

Drug Labeling and Warnings

kids kare by is a Otc medication manufactured, distributed, or labeled by DEN-MAT HOLDINGS, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Stannous Fluoride 0.4% (0.12% w/v fluoride ion)

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities.

Warnings

This is an anticavity fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.

WHEN USING

When using this product it may produce surface staining of the teeth, Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste.
• Apply the get to your teeth and brush thoroghly. 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.
• Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
• Children under 6 years of age: Consult a dentist or doctor.

Other information

Do not use if the foil seal under the cap is torn, cut or missing.

inactive ingredient

Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine

Questions or comments?

1-800-752-2564

Principal Display Panel

kids kare™

Preventative Treatment

0.4% Stannous Fluoride

Brush-On Gel

BERRY FLAVOR

IMPORTANT:

Read directions carefully

Net Wt. 4.3 oz. (121.9 g)

INGREDIENTS AND APPEARANCE

KIDS KARE 
stannous fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59883-404
Route of Administration	DENTAL, ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.969 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
BERRY (UNII: FV3431923Z)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CARBOMER 934 (UNII: Z135WT9208)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59883-404-04	121.9 g in 1 TUBE; Type 0: Not a Combination Product	10/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	10/12/2017

Labeler - DEN-MAT HOLDINGS, LLC. (809857704)