Label: ENAMELON PREVENTIVE TREATMENT- stannous fluoride gel
- NDC Code(s): 48783-500-40
- Packager: Premier Dental Products Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated July 10, 2014
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- Active ingredient
Stannous fluoride 0.40% (0.15% w/v fluoride ion)Close
- Aids in the prevention of caries
- Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
- Helps prevent gingivitis
- Helps interfere with the harmful effects of plaque associated with gingivitis
Keep out of the reach of children.Close
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if gingivitis, bleeding, or redness persists for more than 2 weeks, see your dentist. See your dentist immediately if you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Stop use and ask a dentist if the problem persists or worsens. Do not use this product for sensitivity relief longer than 4 weeks unless recommended by a dentist or doctor.Close
Adults and children 6 years of age or 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 rinse, 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.Close
- Other information
This is an anticavity/fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using. Products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
- Do not use if foil seal is broken or missing
- Keep tightly closed when not in use
- Store at controlled room temperature
- Inactive ingredients
Acesulfame K, calcium sulfate, cocamidopropyl betaine, dimethicone, flavors, glycerin, lauroyl-sarcosine, monosodium phosphate, poloxamer 407, polyethylene glycol, pva/ma copolymer, silica, sucraloseClose
- Questions or comments?
Call toll-free 1-888-670-6100 Monday-Friday 8am – 5pm ESTClose
- Distributed By
- PRINCIPAL DISPLAY PANEL
STRENGTHEN YOUR SMILE!
ACPTM Enamel Therapy
Enamelon Preventive Treatment Gel
NET WT 4.0 OZ (113 g)
- INGREDIENTS AND APPEARANCE
ENAMELON PREVENTIVE TREATMENT
stannous fluoride gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48783-500 Route of Administration DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.00400 g in 1 g Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) CALCIUM SULFATE (UNII: WAT0DDB505) CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%) (UNII: 5216H1HX5F) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) LAUROYL SARCOSINE (UNII: LIJ19P3L6F) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) POLOXAMER 407 (UNII: TUF2IVW3M2) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color white Score Shape Size Flavor MINT (Clean Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48783-500-40 1 in 1 CARTON 1 113 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/2014 Labeler - Premier Dental Products Company (014789663) Establishment Name Address ID/FEI Business Operations Unicep Packaging, LLC 790263909 manufacture(48783-500) , pack(48783-500) , analysis(48783-500)