Label: LEVEL WINTERMINT FIVE WHITENING FORMULA ANTICAVITY- sodium monofluorophosphate paste
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Contains inactivated NDC Code(s)
NDC Code(s): 50001-121-50 - Packager: LEVEL ORAL CARE, LLC
- 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 May 9, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
DIRECTIONS
Adults and children 2 years of age and older:
Apply Level Toothpaste on to a soft bristle toothbrush. Brush thoroughly, preferably after each meal or at least twice a day or as directed by a dentist or doctor
Children under 6 years of age
Instruct in good brushing and rinsing habits (to minimize swallowing). Use a pea-sized amount. Supervise children as necessary until capable of using without supervision.
Children under 2 years of age:
consult a dentist or doctor - INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
Level
Wintermint Five
Whitening Formula
Anticavity Toothpaste
perfect your smile
NET WT. 5.0 OZ (141.7G)
Xylitol
natural enamel protection
True protection with fluoride
Ultra concentrated whitening agents
Active stain removal
Invigorating winter mint
Enamel Guard with pH stabilizers
ACTIVE INGREDIENT:
Sodium monofluorophosphate 0.76%
USES:
Aids in the prevention of dental cavities
DIRECTIONS:
Adults and children 2 years of age and older: Apply Level Toothpaste onto a soft bristle toothbrush. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Use a pea-sized amount. supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor
WARNINGS
Keep out of reach of children under 6 years of age. Do not swallow. if more than used from brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Distributed by:
Level Oral Care, LLC
Jacksonville, FL 32246
www.leveloralcare.com - PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LEVEL WINTERMINT FIVE WHITENING FORMULA ANTICAVITY
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50001-121 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 0.76 g in 100 g Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BICARBONATE (UNII: 8MDF5V39QO) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50001-121-50 141.7 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part356 08/16/2010 Labeler - LEVEL ORAL CARE, LLC (832019124) Establishment Name Address ID/FEI Business Operations AmLion Toothpaste Mfg. Sdn. Bhd. 652244161 manufacture
