Label: MEGAFRESH- sodium fluoride gel, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 54157-102-01, 54157-102-02, 54157-102-03, 54157-102-04, view more54157-102-05, 54157-102-06, 54157-102-07, 54157-102-08, 54157-102-09, 54157-102-10, 54157-102-11, 54157-102-12, 54157-102-13, 54157-102-14, 54157-102-15, 54157-102-16, 54157-102-17, 54157-102-18, 54157-102-19, 54157-102-20 - Packager: American Amenities, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 January 16, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- ASK DOCTOR
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DOSAGE & ADMINISTRATION
Adults and children of two years of age and older: Brush teeth thoroughly, perferrably after each meal or at least twice a day, or as directed by a dentist or a doctor. Instruct children under six years of age in good brushing and rinsing habit (to minimize swollowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: consult a dentist or doctor.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MEGAFRESH
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54157-102 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.10 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) HYDRATED SILICA (UNII: Y6O7T4G8P9) SACCHARIN SODIUM (UNII: SB8ZUX40TY) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54157-102-01 17 g in 1 TUBE 2 NDC:54157-102-02 24 g in 1 TUBE 3 NDC:54157-102-03 35 g in 1 TUBE 4 NDC:54157-102-04 43 g in 1 TUBE 5 NDC:54157-102-05 50 g in 1 TUBE 6 NDC:54157-102-06 70 g in 1 TUBE 7 NDC:54157-102-07 78 g in 1 TUBE 8 NDC:54157-102-08 90 g in 1 TUBE 9 NDC:54157-102-09 100 g in 1 TUBE 10 NDC:54157-102-10 120 g in 1 TUBE 11 NDC:54157-102-11 130 g in 1 TUBE 12 NDC:54157-102-12 150 g in 1 TUBE 13 NDC:54157-102-13 181 g in 1 TUBE 14 NDC:54157-102-14 200 g in 1 TUBE 15 NDC:54157-102-15 4.25 g in 1 POUCH 16 NDC:54157-102-16 3 g in 1 POUCH 17 NDC:54157-102-17 5 g in 1 POUCH 18 NDC:54157-102-18 10 g in 1 POUCH 19 NDC:54157-102-19 71 g in 1 TUBE 20 NDC:54157-102-20 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 11/04/2013 Labeler - American Amenities, Inc. (181454026) Registrant - American Amenities, Inc. (181454026)
