Label: HOME CARE FLUORIDE- stannous fluoride gel
- NDC Code(s): 55346-0402-1
- Packager: Dental Technologies, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 6, 2024
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Keep out of reach of children.
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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.
- Other information
- Inactive ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
HOME CARE FLUORIDE
stannous fluoride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55346-0402 Route of Administration DENTAL, ORAL 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 ASCORBIC ACID (UNII: PQ6CK8PD0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) 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:55346-0402-1 121.9 g in 1 TUBE; Type 0: Not a Combination Product 12/31/1999 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 12/31/1999 Labeler - Dental Technologies, Inc. (148312838) Registrant - Dental Technologies, Inc. (148312838) Establishment Name Address ID/FEI Business Operations Dental Technologies, Inc. 148312838 manufacture(55346-0402) , label(55346-0402) , pack(55346-0402)
