Label: FRESHMINT PREMIUM ANTICAVITY- sodium fluoride paste, dentifrice
- NDC Code(s): 68747-6038-1
- Packager: Dabur India Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC Monograph Drug Product Manufactured Exclusively for Private Label Distributor
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.
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT:
Sodium Fluoride - 0.243% (0.15% w/v fluoride ion)Close
Helps protect teeth and roots against cavities.Close
Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.
- Adults and children 2 years & older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Do not swallow. To minimize swallowing use a pea-sized amount in children under 6 years of age. Supervise children's brushing until good habits are established.
- Children under 2 years: Ask a dentist.
- INACTIVE INGREDIENTS:
Sorbitol, Silica, Treated Water (Aqua), Glycerin, Polyethylene Glycol 1500, Sodium Lauryl Sulphate, Flavor, Titanium Dioxide, Cellulose Gum, Carrageenan, Trisodium Orthophosphate, Sodium Saccharin, Sodium Benzoate, Tetrasodium Pyrophosphate, Methylparaben, Propylparaben, Color: FD & C Blue # 1.Close
- PRINCIPAL DISPLAY PANEL
Principal Display Panel – Tube Label
Premium Anticavity Toothpaste
NET WT. 0.85 ozClose
- INGREDIENTS AND APPEARANCE
FRESHMINT PREMIUM ANTICAVITY
sodium fluoride paste, dentifrice
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68747-6038 Route of Administration DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 2.43 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL SILICON DIOXIDE WATER GLYCERIN POLYETHYLENE GLYCOL 1500 SODIUM LAURYL SULFATE TITANIUM DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE SACCHARIN SODIUM DIHYDRATE SODIUM BENZOATE SODIUM PYROPHOSPHATE METHYLPARABEN PROPYLPARABEN FD&C BLUE NO. 1 Product Characteristics Color Score Shape Size Flavor MINT (MINT) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68747-6038-1 24 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR 01/01/2013 Labeler - Dabur India Limited (650319218) Establishment Name Address ID/FEI Business Operations Dabur India Limited 650599231 MANUFACTURE(68747-6038)