Label: PLAK SMACKER- stannous fluoride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 55346-0412-2 - Packager: Dental Technologies, Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 1, 2015
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- Active Ingredient
- Purpose
- Uses
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Warnings:
This is an anticavity fluoride preventive treatment gel, not a toothpaste.
Read directions carefully before using.
When using this product it may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
- 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:
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INGREDIENTS AND APPEARANCE
PLAK SMACKER
stannous fluoride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55346-0412 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 934 (UNII: Z135WT9208) Product Characteristics Color Score Shape Size Flavor BUBBLE GUM (Bubblegum Burst) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55346-0412-2 121.9 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 12/31/2007 Labeler - Dental Technologies, Inc. (148312838)
