Label: HEAD AND SHOULDERS CLINICAL STRENGTH DANDRUFF DEFENSE DRY SCALP RESCUE- selenium sulfide lotion/shampoo
- NDC Code(s): 69423-523-40
- 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 March 24, 2023
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- SPL UNCLASSIFIED SECTION
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- PRINCIPAL DISPLAY PANEL - BOTTLE LABEL
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INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS CLINICAL STRENGTH DANDRUFF DEFENSE DRY SCALP RESCUE
selenium sulfide lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-523 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) HONEY (UNII: Y9H1V576FH) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69423-523-40 400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/17/2020 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)