Label: HEAD AND SHOULDERS ITCHY SCALP 2IN1- pyrithione zinc lotion/shampoo
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NDC Code(s):
37000-081-01,
37000-081-25,
37000-081-37,
37000-081-40, view more37000-081-61, 37000-081-70, 37000-081-95
- 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 January 24, 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 lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, fragrance, dimethicone, cocamidopropyl betaine, sodium xylenesulfonate, menthol, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, mentha piperita (peppermint) flower/leaf/stem oil, mentha arvensis leaf/stemoil, eucalyptus globulus leaf extract
- Questions (or comments)?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 613 mL Bottle Label
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INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS ITCHY SCALP 2IN1
pyrithione zinc lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-081 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 GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) MENTHOL (UNII: L7T10EIP3A) PEPPERMINT (UNII: V95R5KMY2B) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) GLYCOL DISTEARATE (UNII: 13W7MDN21W) ZINC CARBONATE (UNII: EQR32Y7H0M) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM XYLENESULFONATE (UNII: G4LZF950UR) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM BENZOATE (UNII: OJ245FE5EU) MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-081-70 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2013 12/01/2024 2 NDC:37000-081-40 400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2013 12/01/2024 3 NDC:37000-081-25 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2016 4 NDC:37000-081-01 2 in 1 CELLO PACK 04/20/2020 11/01/2022 4 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 5 NDC:37000-081-95 950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/01/2021 12/01/2024 6 NDC:37000-081-37 370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/15/2022 7 NDC:37000-081-61 613 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)