1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db

SPL v7
SPL
SPL Set ID 1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db
Route
dental
Published
Effective Date 2019-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.116 g)
Inactive Ingredients
glycerin water carbomer homopolymer type c (allyl pentaerythritol crosslinked) carboxymethylcellulose sodium malic acid xanthan gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2013-01-05

Purpose

Fluoride preventive treatment gel

Description

Stannous Fluoride 0.4%


Medication Information

Warnings and Precautions

Warning

Uses
  • Home Care is a stable fluoride gel for home use.
  • Aids in the prevention of dental decay.
Purpose

Fluoride preventive treatment gel

Directions

Adults and children 6 years of age and older: Twist off cap to remove foil seal. 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. 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

Store at controlled room temperature 59° - 86°F (15° - 30°C).

Inactive Ingredients

Carbopol, Flavor, Glycerine, Malic Acid, Sodium Carboxymethylcellulose, Water, Xanthan Gum.

Description

Stannous Fluoride 0.4%

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 51945-4

Active Ingredient

Stannous Fluoride 0.4%

Questions Or Comments?

1-800-333-3131 or www.keystoneind.com


Structured Label Content

Warnings and Precautions (34071-1)

Warning

Uses
  • Home Care is a stable fluoride gel for home use.
  • Aids in the prevention of dental decay.
Purpose

Fluoride preventive treatment gel

Directions

Adults and children 6 years of age and older: Twist off cap to remove foil seal. 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. 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

Store at controlled room temperature 59° - 86°F (15° - 30°C).

Inactive Ingredients

Carbopol, Flavor, Glycerine, Malic Acid, Sodium Carboxymethylcellulose, Water, Xanthan Gum.

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 51945-4 (51945-4)

Active Ingredient

Stannous Fluoride 0.4%

Questions Or Comments? (Questions or comments?)

1-800-333-3131 or www.keystoneind.com


Advanced Ingredient Data


Raw Label Data

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