Scotts Select Homecare

SCOTTS SELECT HOMECARE- sodium fluoride gel
Scott’s Dental Supply, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

1.1% Sodium Fluoride.

Uses:

Aids in prevention of dental caries and hypersensitivity. Use as directed by your dentist.

Warnings:

Do not swallow. To avoid ingestion, supervision is required while children are using the product. Keep out of reach of children.

Directions:

Adults and children 6 years of age and older:

  • Twist off cap to remove foil seal.
  • Use once daily after brushing teeth thoroughly with toothpaste.
  • Apply a small amount to a toothbrush and brush thoroughly on all tooth surfaces for at least 1 minute.
  • Expectorate, do not swallow, do not eat, drink or rinse for at least 30 minutes.

Children under 6 years of age:

  • Consult a dentist or physcian.

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

Inactive Ingredients:

Calcium Caseinate, Citric Acid, Flavor, Glycerine, Glydant, Sodium Benzoate, Sodium Hexameta Phosphate, Sodium Saccharine, TriCalcium Phosphate, Vitamin E, Water, Xanthan Gum, Xylitol.

SCOTTSNEUTRAL1.1MINT
(click image for full-size original)

SCOTTS SELECT HOMECARE
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69638-058
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.597 g in 120 g
Inactive Ingredients
Ingredient Name Strength
CASEIN
CITRIC ACID MONOHYDRATE
GLYCERIN
DMDM HYDANTOIN
SODIUM BENZOATE
SODIUM POLYMETAPHOSPHATE
SACCHARIN SODIUM
TRICALCIUM PHOSPHATE
.ALPHA.-TOCOPHEROL
WATER
XANTHAN GUM
XYLITOL
Product Characteristics
Color white Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69638-058-04 120 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2013
Labeler — Scott’s Dental Supply, LLC (137217043)

Revised: 03/2015 Scott’s Dental Supply, LLC

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