Label: HEAD AND SHOULDERS CLINICAL ITCH RELIEF SCALP MIST- pyrithione zinc liquid
- NDC Code(s): 69423-529-12
- 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 January 27, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
- Directions
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Inactive ingredients
Water, niacinamide, PEG-40 hydrogenated castor oil, phenoxyethanol, caffeine, bis-PEG/PPG-16/16 PEG/PPG-16/16 dimethicone, glycerin, benzyl alcohol, fragrance, menthol, acrylates/C10-30 alkyl acrylate crosspolymer, panthenol, tetrahydroxypropyl ethylenediamine, ethylhexylglycerin, mentha piperita (peppermint) oil, mentha arvensis leaf oil.
- Questions (or comments)?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 125 mL bottle label
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INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS CLINICAL ITCH RELIEF SCALP MIST
pyrithione zinc liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-529 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 0.1 g in 100 mL Inactive Ingredients Ingredient Name Strength ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) WATER (UNII: 059QF0KO0R) BENZYL ALCOHOL (UNII: LKG8494WBH) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) NIACINAMIDE (UNII: 25X51I8RD4) PANTHENOL (UNII: WV9CM0O67Z) CAFFEINE (UNII: 3G6A5W338E) BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE (UNII: 55A74AJ3KB) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETOL (UNII: Q4R969U9FR) PEPPERMINT OIL (UNII: AV092KU4JH) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69423-529-12 125 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)