Label: PERIOE WHITENING ESSENTIALS FRESH ALOE GREEN MINT- sodium fluoride paste, dentifrice
- NDC Code(s): 43136-802-01
- Packager: Tai Guk Pharm. Co., Ltd.
- 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 March 31, 2020
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- Drug Facts
- Active Ingredient
- Purpose
- Use
- Warnings
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Directions
Adults and children 6 years and older Brush teeth thoroughly after each means or at least twice a day, or as directed by a dentist and physician. Do not swallow. Children between 6 and 12 years To minimize swallowing, use a pea-sized amount and supervise children's brushing and rinsing until good habits are established. Children under 6 years Ask a dentist or physician. -
Inactive Ingredients
glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, trisodium phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, sodium saccharin, sucralose, xanthan gum, titanium dioxide, mica, charcoal powder, citru limon(lemon) fruit extract, sodium chloride, aloe extract
- QUESTIONS
- Principal Display Panel - 156 g Tube Carton
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INGREDIENTS AND APPEARANCE
PERIOE WHITENING ESSENTIALS FRESH ALOE GREEN MINT
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43136-802 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.6 mg in 1 g Inactive Ingredients Ingredient Name Strength HEXASODIUM HEXAMETAPHOSPHATE (UNII: N40N91DW96) CARRAGEENAN (UNII: 5C69YCD2YJ) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCRALOSE (UNII: 96K6UQ3ZD4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYDRATED SILICA (UNII: Y6O7T4G8P9) XANTHAN GUM (UNII: TTV12P4NEE) MICA (UNII: V8A1AW0880) ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALOE (UNII: V5VD430YW9) Product Characteristics Color green Score Shape Size Flavor MINT (Fresh Aloe) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43136-802-01 1 in 1 CARTON 03/31/2020 1 156 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 03/31/2020 Labeler - Tai Guk Pharm. Co., Ltd. (689060246) Establishment Name Address ID/FEI Business Operations Tai Guk Pharma. Co., Ltd. 689060246 manufacture(43136-802)