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| NDC | 63783-005-04, 63783-006-04, 63783-007-04, 63783-008-04, 63783-009-04, 63783-015-04 |
| Set ID | cbf7907e-72c7-4328-8bd4-bf70daa35ef9 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Massco Dental A Division of Dunagin Pharmaceuticals |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART355 |
- ACTIVE INGREDIENT
- INACTIVE INGREDIENTS
- USE
- KEEP OUT OF REACH OF CHILDREN
-
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. -
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.
- QUESTIONS ? COMMENTS ?
- WARNINGS
- PACKAGE LABEL
-
INGREDIENTS AND APPEARANCE
KIDS CHOICE
stannous fluoride gel, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63783-005 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 BUBBLE GUM (BUBBLE GUM) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63783-005-04 120 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 KIDS CHOICE
stannous fluoride gel, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63783-006 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 CREME DE MENTHE (HINT OF MINT) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63783-006-04 120 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 KIDS CHOICE
stannous fluoride gel, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63783-007 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 LIME (LIMEAIDE) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63783-007-04 120 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 KIDS CHOICE
stannous fluoride gel, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63783-008 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 GRAPE (GRAPE) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63783-008-04 120 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 KIDS CHOICE
stannous fluoride gel, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63783-009 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 CHERRY (CHERRY) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63783-009-04 120 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 KIDS CHOICE
stannous fluoride gel, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63783-015 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 COTTON CANDY (COTTON CANDY) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63783-015-04 120 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(63783-005, 63783-006, 63783-007, 63783-008, 63783-009, 63783-015)
