HIMALAYA PINK SALT INTENSIVE WHITENING SPEARMINT- sodium fluoride paste, dentifrice

HIMALAYA PINK SALT Intensive Whitening Spearmint by

Drug Labeling and Warnings

HIMALAYA PINK SALT Intensive Whitening Spearmint by is a Otc medication manufactured, distributed, or labeled by LG H&H Co.,Ltd., Tai Guk Pharma. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

SODIUM FLUORIDE 0.243%
(0.15% w/v fluoride ion)

Purpose

Anticavity
toopaste

Use

helps protect against cavities

Warnings

Keep out of reach of children under 6 years of age. Do not swallow.
If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center right away.
If an allergic reaction develops, discontinue use immediately

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.

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

Questions?

1-86-993-4709

SPL UNCLASSIFIED SECTION

DISTR. LG H&H Co., Ltd.
58, SAEMUNAN-RO, JONGNO-GU, SEOUL, KOREA

MADE IN KOREA

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:

HIMALAYA
PINK SALT

Intensive Whitening

fluoride anticavity
toothpaste_ spearmint

9X
WHITER*

CLINICALLY PROVEN**
24HR STAIN RESISTANCE***
ENAMEL STRENGTHENING

NET WT. 4.2 OZ (120 g)

INGREDIENTS AND APPEARANCE

HIMALAYA PINK SALT INTENSIVE WHITENING SPEARMINT 
sodium fluoride paste, dentifrice

Product 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)