Label: HEAD AND SHOULDERS SMOOTH AND SILKY- pyrithione zinc lotion/shampoo
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NDC Code(s):
37000-094-10,
37000-094-37,
37000-094-38,
37000-094-40, view more37000-094-50, 37000-094-61, 37000-094-65, 37000-094-70, 37000-094-90
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
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 February 24, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
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Inactive ingredients
Water, sodium lauryl sulfate, glycol distearate, zinc carbonate, sodiumchloride, cocamidopropyl betaine, fragrance, sodium xylenesulfonate, dimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, sodium laureth sulfate,methylchloroisothiazolinone, methylisothiazolinone
- Questions (or comments)?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 370 mL Bottle Label
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INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS SMOOTH AND SILKY
pyrithione zinc lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-094 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 1 g in 100 mL Inactive Ingredients Ingredient Name Strength COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) ZINC CARBONATE (UNII: EQR32Y7H0M) WATER (UNII: 059QF0KO0R) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) GLYCOL DISTEARATE (UNII: 13W7MDN21W) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM XYLENESULFONATE (UNII: G4LZF950UR) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BENZOATE (UNII: OJ245FE5EU) MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-094-10 10 mL in 1 POUCH; Type 0: Not a Combination Product 09/01/2013 2 NDC:37000-094-70 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2013 12/21/2019 3 NDC:37000-094-40 400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2013 12/21/2019 4 NDC:37000-094-90 90 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/11/2017 02/28/2023 5 NDC:37000-094-38 380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/11/2017 01/01/2025 6 NDC:37000-094-65 650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/11/2017 01/01/2025 7 NDC:37000-094-50 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/15/2020 08/30/2021 8 NDC:37000-094-37 370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/15/2022 9 NDC:37000-094-61 613 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M032 09/01/2013 Labeler - The Procter & Gamble Manufacturing Company (004238200)