Label: HEAD AND SHOULDERS DRY SCALP CARE- pyrithione zinc lotion/shampoo
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NDC Code(s):
37000-092-01,
37000-092-10,
37000-092-25,
37000-092-37, view more37000-092-40, 37000-092-61, 37000-092-70, 37000-092-71, 37000-092-83, 37000-092-95
- 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 28, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
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Inactive ingredients
Water, sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, sodium xylenesulfonate, zinc carbonate, glycol distearate, fragrance, sodium chloride, dimethiconol, sodium benzoate, guar hydroxypropyltrimonium chloride, dimethicone,TEA-dodecylbenzenesulfonate, magnesium carbonate hydroxide, trideceth-10, prunus amygdalus dulcis (sweet almond) oil, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone
- Questions (or comments)?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 835mL Bottle Label
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INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS DRY SCALP CARE
pyrithione zinc lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-092 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 DIMETHICONOL GUM (UNII: 4MJ9GU3T1P) TRIDECETH-10 (UNII: G624N6MSBA) TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) WATER (UNII: 059QF0KO0R) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) SODIUM LAURYL SULFATE (UNII: 368GB5141J) DIMETHICONE (UNII: 92RU3N3Y1O) ZINC CARBONATE (UNII: EQR32Y7H0M) GLYCOL DISTEARATE (UNII: 13W7MDN21W) SODIUM XYLENESULFONATE (UNII: G4LZF950UR) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BENZOATE (UNII: OJ245FE5EU) MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4) ALMOND OIL (UNII: 66YXD4DKO9) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) BENZYL ALCOHOL (UNII: LKG8494WBH) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-092-70 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2013 10/05/2018 2 NDC:37000-092-10 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2013 10/05/2018 3 NDC:37000-092-40 400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/22/2014 01/01/2025 4 NDC:37000-092-25 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/30/2015 04/01/2023 5 NDC:37000-092-95 950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 12/01/2016 01/01/2025 6 NDC:37000-092-71 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/23/2018 01/01/2025 7 NDC:37000-092-01 2 in 1 CELLO PACK 07/15/2020 7 950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 8 NDC:37000-092-37 370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2022 9 NDC:37000-092-61 613 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2022 10 NDC:37000-092-83 835 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 12/01/2022 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)