Label: STANGARD- topical snf fluoride gel gel
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Contains inactivated NDC Code(s)
NDC Code(s): 10866-0271-1 - Packager: Pascal Company, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated December 19, 2022
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- Active Ingredient:
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Warnings:
This is an anticavity preventive treatmeng gel, not a toothpaste.
Read directions carefully before using
Keep out of reach of children
If more than amount used for brushing is swallowed, seek professional assistance or contact a Poison Control Center immediately.
Do not use if foil seal is missing or damaged.
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Directions
Adults and children 6 years of age and older:
Before dispensing, remove cap and peel off seal
Use once daily after brushing with toothpaste
Apply a small amount of gel totoothbrush and brush teeth thoroughly
Allow the gel to remain on teeth for one minute
Spit out the gel. Do not swallow.
Do not eat, drink or rinse 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 adult supervision.
Children under age 6: Consult a dentist or physician.
- Inactive Ingredients
- Other Information:
- StanGard
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INGREDIENTS AND APPEARANCE
STANGARD
topical snf fluoride gel gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10866-0271 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 3.8 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) 12.56 mg in 1 g Product Characteristics Color Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10866-0271-1 122 g in 1 TUBE; Type 0: Not a Combination Product 04/01/1981 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 04/01/1981 Labeler - Pascal Company, Inc. (009260217) Registrant - Pascal Company, Inc. (009260217) Establishment Name Address ID/FEI Business Operations Pascal Company, Inc. 009260217 manufacture(10866-0271)