Label: DOCTORS CHOICE- stanous fluoride gel, dentifrice
DOCTORS CHOICE- stannous fluoride gel, dentifrice
- NDC Code(s): 63783-011-04, 63783-012-04
- Packager: Massco Dental A Division of Dunagin Pharmaceuticals
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Drug Label Information
Updated December 17, 2023
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENTS
- USE
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS FOR USE
Adults and Children 12 years and Older: Use after regular brushing and flossing. Place gel across length of toothbrush. Brush Thoroughly. Keep on teeth for 1 - 1 1/2 minutes and then expectorate (spit out). Do not swallow. Use once a day for cavity prevention. Supervise children until capable of using without supervision.
Children 6-11 Years: See directions above. Adult supervision required.
Children Under 6: Consult a Dentist or Physician.
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OTHER INFORMATION
This is a fluoride prevention treatment gel, not a toothpaste. Read directions carefully before use. This product may produce surface discoloration of the teeth. Adequate toothbrushing may prevent discoloration. Discoloration is not harmful or permanent and may be removed by a dental professional. Do not freeze or expose to extreme heat.
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INGREDIENTS AND APPEARANCE
DOCTORS CHOICE
stanous fluoride gel, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63783-011 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.12 g in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color Score Shape Size Flavor SPEARMINT (MINT FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63783-011-04 120 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 01/01/1989 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/1989 DOCTORS CHOICE
stannous fluoride gel, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63783-012 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.12 g in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color Score Shape Size Flavor CINNAMON (CINNAMON FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63783-012-04 120 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 01/01/1989 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/1989 Labeler - Massco Dental A Division of Dunagin Pharmaceuticals (008081858) Registrant - Massco Dental A Division of Dunagin Pharmaceuticals (008081858) Establishment Name Address ID/FEI Business Operations Massco Dental A Division of Dunagin Pharmaceuticals 008081858 manufacture(63783-011, 63783-012)
