Label: HEAD AND SHOULDERS CLINICAL STRENGTH DANDRUFF DEFENSE INTENSIVE ITCH RELIEF- selenium sulfide lotion/shampoo
- NDC Code(s): 69423-526-01, 69423-526-40
- Packager: The Procter & Gamble Manufacturing Company
- 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 May 8, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
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Inactive ingredients
Water, sodium lauryl sulfate, glycol distearate, sodium chloride, cocamidopropyl betaine, sodium citrate, sodium xylenesulfonate, dimethicone,menthol, fragrance, citric acid, sodium benzoate, tetrasodium EDTA, hydroxypropyl methylcellulose, mentha piperita (peppermint) oil,mentha arvensis leaf oil, red 4.
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - BOTTLE LABEL
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INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS CLINICAL STRENGTH DANDRUFF DEFENSE INTENSIVE ITCH RELIEF
selenium sulfide lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-526 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) EDETATE DISODIUM (UNII: 7FLD91C86K) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) GLYCOL DISTEARATE (UNII: 13W7MDN21W) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM XYLENESULFONATE (UNII: G4LZF950UR) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM BENZOATE (UNII: OJ245FE5EU) FD&C RED NO. 4 (UNII: X3W0AM1JLX) SODIUM CITRATE (UNII: 1Q73Q2JULR) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PEPPERMINT OIL (UNII: AV092KU4JH) MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69423-526-40 400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/17/2020 2 NDC:69423-526-01 2 in 1 CELLO PACK 01/17/2023 2 400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M032 11/17/2020 Labeler - The Procter & Gamble Manufacturing Company (004238200)