HIMALAYA PINK SALT PURPLE COLOR CORRECTOR PLUS INTENSIVE WHITENING VANILLA MINT- sodium fluoride paste, dentifrice

HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla Mint by

Drug Labeling and Warnings

HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla Mint by is a Otc medication manufactured, distributed, or labeled by Tai Guk Pharma. Co., Ltd., LG H&H 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, SODIUM LAURYL SULFATE, FLAVOR(AROMA), TRIPOTASSIUM PHOSPHATE, CARRAGEENAN, POTASSIUM PHOSPHATE, POLOXAMER 407, SODIUM SACCHARIN, SODIUM CHLORIDE, ALGIN, MICA, TOCOPHERYL ACETATE, XANTHAN GUM, BLUE 1 LAKE, SUCRALOSE, TITANIUM DIOXIDE, RED 33

Questions?

1-866-993-4709

SPL UNCLASSIFIED SECTION

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

MADE IN KOREA

SPL UNCLASSIFIED SECTION

• 2.9X tone-up effect in just one use by reducing yellowness*
• Clinically proven to whiten teeth 9.6X more than regular toothpaste*
• Formulated without parabens, gluten, phthalates, triclosan
• U.S. patented formula***

* Compared to regular toothpaste without SHMP
** 38% higher prevention compared to regular toothpaste without SHMP
*** Patent : US 11,701, 313 B2

Principal Display Panel:

HIMALAYA
PINK SALT

Purple Color Corrector
+ Intensive Whitening

fluoride anticavity
toothpaste_ vanilla mint

2.9X
TONE-UP*

9.6X WHITENING*
24 HR STAIN RESISTANCE**
ENAMEL STRENGTHENING

NET WT. 3.5 OZ (100 g)

INGREDIENTS AND APPEARANCE

HIMALAYA PINK SALT PURPLE COLOR CORRECTOR PLUS INTENSIVE WHITENING VANILLA MINT 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43136-593
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)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
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)
MICA (UNII: V8A1AW0880)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)
XANTHAN GUM (UNII: TTV12P4NEE)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLOXAMER 407 (UNII: TUF2IVW3M2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	MINT (Vanilla)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43136-593-11	1 in 1 CARTON	11/01/2024
1		100 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	11/01/2024

Labeler - Tai Guk Pharma. Co., Ltd. (689060246)

Registrant - LG H&H Co.,Ltd. (688276187)

Establishment
Name	Address	ID/FEI	Business Operations
Tai Guk Pharma. Co., Ltd.		689060246	manufacture(43136-593)