SPL v5
SPL
SPL Set ID 048c9978-e32e-4f77-9a4e-40acd5fcdfaf
Route
DENTAL
Published
Effective Date 2017-12-22
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

Description

Stannous Fluoride 0.4%

Purpose

Fluoride preventive treatment gel.


Medication Information

Purpose

Fluoride preventive treatment gel.

Description

Stannous Fluoride 0.4%

Uses:
  • Home Care is a stable, water-free fluoride gel for home use.
  • Aids in the prevention of dental decay.
Section 50565-1

Keep out of reach of children.

Section 51945-4

Purpose:

Fluoride preventive treatment gel.

Warnings:
  • If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
  • 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 dentist.
  • This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.
Directions:

Adults and children 6 years of age and older: Twist off cap and 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.

Active Ingredient:

Stannous Fluoride 0.4%

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.


Structured Label Content

Uses:
  • Home Care is a stable, water-free fluoride gel for home use.
  • Aids in the prevention of dental decay.
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Purpose:

Fluoride preventive treatment gel.

Warnings:
  • If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
  • 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 dentist.
  • This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.
Directions:

Adults and children 6 years of age and older: Twist off cap and 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.

Active Ingredient:

Stannous Fluoride 0.4%

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.


Advanced Ingredient Data


Raw Label Data

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