Label: ACCLEAN PLUS- sodium flouride gel, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 0404-6918-01, 0404-6919-01 - Packager: Henry Schein, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Drug Label Information
Updated November 3, 2018
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- Inactive Ingredients
- Active Ingredient
- Indications
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Directions
Adults and children six years of age and older should brush with Acclean® Plus Home Care Gel once at bedtime (or as directed by physician or dentist). Apply a thin bead of gel to toothbrush and brush for at least one minute, making sure all tooth surfaces are covered. ADULTS: Expectorate thoroughly. Do not rinse, drink or eat for at least 30 minutes after use. CHILDREN SIX YEARS OF AGE AND OLDER: Expectorate and rinse thoroughly. If recommended by your dental professional, this product can be used in place of your regular toothpaste. Read all instructions and prescribing information before using this product.
- Warning
- Precautions
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Package Label
NDC 0404-6918-01
HENRY SCHEIN®
ACCLEAN® PLUS
HOME CARE GEL
HENRY SCHEIN SEAL OF EXCELLENCE®
1.1% NEUTRAL SODIUM FLUORIDE
Contains MCH-C*
*(Micronized Calcium Hydroxyapatite & Casein)
MINT FLAVOR
Net Wt. 1.4 oz. (40g)
Rx Only
NDC 0404-6919-01
HENRY SCHEIN®
ACCLEAN® PLUS
HOME CARE GEL
HENRY SCHEIN SEAL OF EXCELLENCE®
1.1% NEUTRAL SODIUM FLUORIDE
Contains MCH-C*
*(Micronized Calcium Hydroxyapatite & Casein)
BUBBLE GUM FLAVOR
Net Wt. 1.4 oz. (40g)
Rx Only
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INGREDIENTS AND APPEARANCE
ACCLEAN PLUS
sodium flouride gel, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0404-6918 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 11 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) XYLITOL (UNII: VCQ006KQ1E) Carboxymethylcellulose (UNII: 05JZI7B19X) Sodium Benzoate (UNII: OJ245FE5EU) Titanium Dioxide (UNII: 15FIX9V2JP) Sucralose (UNII: 96K6UQ3ZD4) Casein (UNII: 48268V50D5) Sodium Phosphate, Monobasic (UNII: 3980JIH2SW) Tribasic Calcium Phosphate (UNII: 91D9GV0Z28) Silicon Dioxide (UNII: ETJ7Z6XBU4) Sodium Phosphate, Dibasic (UNII: GR686LBA74) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0404-6918-01 40 g in 1 TUBE; Type 0: Not a Combination Product 04/15/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/15/2014 ACCLEAN PLUS
sodium flouride gel, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0404-6919 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 11 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) XYLITOL (UNII: VCQ006KQ1E) Carboxymethylcellulose (UNII: 05JZI7B19X) Sodium Benzoate (UNII: OJ245FE5EU) Titanium Dioxide (UNII: 15FIX9V2JP) Sucralose (UNII: 96K6UQ3ZD4) Casein (UNII: 48268V50D5) Sodium Phosphate, Monobasic (UNII: 3980JIH2SW) Tribasic Calcium Phosphate (UNII: 91D9GV0Z28) Silicon Dioxide (UNII: ETJ7Z6XBU4) Sodium Phosphate, Dibasic (UNII: GR686LBA74) Product Characteristics Color Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0404-6919-01 40 g in 1 TUBE; Type 0: Not a Combination Product 04/15/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/15/2014 Labeler - Henry Schein, Inc. (012430880) Registrant - Henry Schein, Inc. (012430880) Establishment Name Address ID/FEI Business Operations Medical Products Laboratories, Inc. 002290302 manufacture(0404-6918, 0404-6919)