Label: HEAD AND SHOULDERS DRY SCALP CARE 2IN1- pyrithione zinc lotion/shampoo
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NDC Code(s):
37000-093-01,
37000-093-02,
37000-093-10,
37000-093-11, view more37000-093-12, 37000-093-25, 37000-093-37, 37000-093-40, 37000-093-61, 37000-093-70, 37000-093-83, 37000-093-95
- 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 February 28, 2023
If you are a consumer or patient please visit this version.
- 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 laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, sodium xylenesulfonate, zinc carbonate, glycol distearate, fragrance, sodium chloride, dimethiconol, dimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride, TEA-dodecylbenzenesulfonate, trideceth-10, magnesium carbonate hydroxide, prunus amygdalus dulcis (sweet almond) oil, benzyl alcohol, 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 DRY SCALP CARE 2IN1
pyrithione zinc lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-093 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 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) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) DIMETHICONOL GUM (UNII: 4MJ9GU3T1P) TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN) TRIDECETH-10 (UNII: G624N6MSBA) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-093-70 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2013 01/01/2025 2 NDC:37000-093-10 1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/01/2013 09/30/2018 3 NDC:37000-093-11 1180 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/01/2013 4 NDC:37000-093-40 400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2013 01/01/2025 5 NDC:37000-093-25 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2013 6 NDC:37000-093-95 950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 12/01/2016 7 NDC:37000-093-12 1280 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/17/2017 01/01/2025 8 NDC:37000-093-01 2 in 1 CELLO PACK 09/01/2021 01/01/2025 8 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 9 NDC:37000-093-02 2 in 1 CELLO PACK 01/01/2021 9 950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10 NDC:37000-093-61 613 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2022 11 NDC:37000-093-37 370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2022 12 NDC:37000-093-83 835 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)