Label: PLAK SMACKER- stannous fluoride gel
- NDC Code(s): 72796-0411-1
- Packager: Young Innovations, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 6, 2024
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Directions
- Adults and children 6 years of age and older: 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.
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INGREDIENTS AND APPEARANCE
PLAK SMACKER
stannous fluoride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72796-0411 Route of Administration ORAL, DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.969 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) MINT (UNII: FV98Z8GITP) GLYCERIN (UNII: PDC6A3C0OX) ASCORBIC ACID (UNII: PQ6CK8PD0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) TROLAMINE (UNII: 9O3K93S3TK) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72796-0411-1 121.9 g in 1 TUBE; Type 0: Not a Combination Product 12/31/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 12/31/2007 Labeler - Young Innovations, Inc. (004193103)