Label: HIMALAYA PINK SALT INTENSIVE WHITENING SPEARMINT- sodium fluoride paste, dentifrice
- NDC Code(s): 53208-591-20
- Packager: LG H&H Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 29, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
- adults and children 2 years of age and and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist.
- do not swallow.
- to minimize swallowing use a pea-sized amount in children under 6.
- supervise children's brushing until good habits are established.
- children under 2 years: ask a dentist.
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Inactive ingredients
GLYCERIN, HYDRATED SILICA, SODIUM HEXAMETAPHOSPHATE, WATER, PEG-6, ZINC STEARATE, COCAMIDOPROPYL BETAINE, FLAVOR, SODIUM LAURYL SULFATE, CARRAGEENAN, POTASSIUM PHOSPHATE (tribasic), TITANIUM DIOXIDE, POTASSIUM PHOSPHATE (monobasic), POLOXAMER 407, SODIUM SACCHARIN, ALGIN, SODIUM CHLORIDE, XANTHAN GUM, SUCRALOSE, XYLITOL, CI 17200, CI 15985
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- SPL UNCLASSIFIED SECTION
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SPL UNCLASSIFIED SECTION
- Visibly whiter teeth in 1 week**
- Provides 24 hour stain resistance***
- Formulated without parabens, gluten, phthalates, triclosan
- U.S. patented formula***
* Compared to regular toothpaste without SHMP.IADR2024 (in-vitro)
** Clinically proven whitening. Improves 1.42 levels of VITA classic Shade Guide vs. 1 week before
*** 38% higher prevention compared to regular toothpaste without SHMP.IADR2024 (in-vitro)
**** Patent : US 11,701, 313 B2 - Principal Display Panel:
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INGREDIENTS AND APPEARANCE
HIMALAYA PINK SALT INTENSIVE WHITENING SPEARMINT
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53208-591 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength POTASSIUM PHOSPHATE, TRIBASIC (UNII: 16D59922JU) GLYCERIN (UNII: PDC6A3C0OX) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) XYLITOL (UNII: VCQ006KQ1E) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SODIUM ALGINATE (UNII: C269C4G2ZQ) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) ZINC STEARATE (UNII: H92E6QA4FV) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARRAGEENAN (UNII: 5C69YCD2YJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 33 (UNII: 9DBA0SBB0L) MONOPOTASSIUM PHOSPHITE (UNII: 59RSS63D8J) XANTHAN GUM (UNII: TTV12P4NEE) SUCRALOSE (UNII: 96K6UQ3ZD4) POLOXAMER 407 (UNII: TUF2IVW3M2) Product Characteristics Color pink Score Shape Size Flavor SPEARMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53208-591-20 1 in 1 CARTON 03/29/2024 1 120 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 Drug M021 03/29/2024 Labeler - LG H&H Co.,Ltd. (688276187) Establishment Name Address ID/FEI Business Operations Tai Guk Pharma. Co., Ltd. 689060246 manufacture(53208-591)
