Label: DR. GROOT ANTI-DANDRUFF SCALP CARE- salicylic acid shampoo
- NDC Code(s): 43136-701-01
- 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 September 15, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient
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Inactive Ingredients
water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, disodium cocoyl glutamate, sodium chloride, polyquaternium-7, fragrance, sodium cocoyl glutamate, sodium benzoate, PEG-40 hydrogenated castor oil, menthol, tetrasodium EDTA, citric acid, biotin, caffeine, hexylene glycol, honey, niacinamide, panthenol, sodium citrate, polysorbate 20, alcohol, butylene glycol, propolis extract, houttuynia cordata extract, rosmarinus officinalis (rosemary) leaf extract, zingiber officinale (ginger) root extract
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- PRINCIPAL DISPLAY PANEL - 300 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
DR. GROOT ANTI-DANDRUFF SCALP CARE
salicylic acid shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43136-701 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43136-701-01 300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 09/15/2002 Labeler - TAI GUK PHARM. CO., LTD (689060246) Establishment Name Address ID/FEI Business Operations TAI GUK PHARM. CO., LTD 689060246 manufacture(43136-701)