Kids Kare Stannous Fluoride

Kids Kare Stannous Fluoride
SPL v4
SPL
SPL Set ID 66d7ae1f-ff7a-7fe4-e053-2991aa0a9f91
Routes
DENTAL ORAL
Published
Effective Date 2018-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.969 mg)
Inactive Ingredients
Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Glycerin Trolamine Berry Anhydrous Citric Acid Ascorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-10-12

Description

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

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

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

Uses

Aids in the prevention of dental cavities.

Section 50565-1

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.

Section 50567-7

When using this productit 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.

Warnings

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

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.
Active Ingredient

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

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)


Structured Label Content

Uses

Aids in the prevention of dental cavities.

Section 50565-1 (50565-1)

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.

Section 50567-7 (50567-7)

When using this productit 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.

Purpose

Anticavity

Warnings

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

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.
Active Ingredient (Active ingredient)

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

Other Information (Other information)

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

Inactive Ingredient (inactive ingredient)

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

Questions Or Comments? (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)


Advanced Ingredient Data


Raw Label Data

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