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Himalaya pink salt purple color corrector plus intensive whitening toothpaste - Medication Information

Product NDC Code 43136-592
Drug Name

Himalaya pink salt purple color corrector plus intensive whitening toothpaste

Type Brand
Active Ingredients
Sodium fluoride 1.5 mg/g
Route DENTAL
Dosage Form PASTE, DENTIFRICE
RxCUI drug identifier 891775
Application Number M021
Labeler Name Tai Guk Pharm. Co., Ltd.
Packages
Package NDC Code Description
43136-592-10 1 tube in 1 carton (43136-592-10) / 100 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient SODIUM FLUORIDE 0.243% (0.15% w/v fluoride ion)

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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 ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients GLYCERIN, HYDRATED SILICA, SODIUM HEXAMETAPHOSPHATE, WATER, PEG-6, ZINC STEARATE, COCAMIDOPROPYL BETAINE, FLAVOR, SODIUM LAURYL SULFATE, CARRAGEENAN, POTASSIUM PHOSPHATE (tribasic), POTASSIUM PHOSPHATE (monobasic), POLOXAMER 407, SODIUM SACCHARIN, ALGIN, SODIUM CHLORIDE, TOCOPHERYL ACETATE, XANTHAN GUM, CI 42090, SUCRALOSE, TITANATED MICA, CI 17200

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use helps protect against cavities

Purpose

Information about the drug product’s indications for use.
Purpose Anticavity toopaste

Spl product data elements

Usually a list of ingredients in a drug product.
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Toothpaste Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION POTASSIUM PHOSPHATE, TRIBASIC GLYCERIN COCAMIDOPROPYL BETAINE WATER SACCHARIN SODIUM .ALPHA.-TOCOPHEROL ACETATE, DL- FD&C BLUE NO. 1 ALUMINUM LAKE SODIUM ALGINATE SODIUM CHLORIDE POLYETHYLENE GLYCOL 300 ZINC STEARATE HYDRATED SILICA SODIUM POLYMETAPHOSPHATE SODIUM LAURYL SULFATE CARRAGEENAN MICA D&C RED NO. 33 POTASSIUM PHOSPHATE, MONOBASIC XANTHAN GUM SUCRALOSE POLOXAMER 407 TITANIUM DIOXIDE Vanilla

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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) himalaya_pink_salt_purple_color_corrector-intensive_whitening_oc himalaya_pink_salt_purple_color_corrector-intensive_whitening_tube

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts DISTR. LG H&H Co., Ltd. 58, SAEMUNAN-RO, JONGNO-GU, SEOUL, KOREA MADE IN KOREA 2.9X tone-up effect in just one use by reducing yellowness** Clinically proven to white 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

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-866-993-4709

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API