Label: DENTAL PRO- sodium fluoride mouthwash
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Contains inactivated NDC Code(s)
NDC Code(s): 41525-6001-1, 41525-6001-2 - Packager: PBS Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
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 September 11, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
purified water, ethyl alcohol, allantoin, glycerin, xylitol, sodium saccharin, green tea, malic acid, lactic acid, sodium benzoate, citric acid peg-40 hydrogenated castor oil, sodium citrate, l-menthol, red ginseng ext, ulmus ext, red ginseng fragrance, mint fragrance, houttuynia ext, propolis ext, caramel color
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DENTAL PRO
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41525-6001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.02 mg in 100 mL Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41525-6001-1 250 mL in 1 BOTTLE 2 NDC:41525-6001-2 600 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 09/11/2014 Labeler - PBS Co., Ltd. (690329669) Registrant - PBS Co., Ltd. (690329669) Establishment Name Address ID/FEI Business Operations PBS Co., Ltd. 690329669 manufacture(41525-6001)