Label: HEAD AND SHOULDERS GREEN APPLE 2IN1- pyrithione zinc lotion/shampoo
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NDC Code(s):
37000-078-01,
37000-078-02,
37000-078-11,
37000-078-12, view more37000-078-25, 37000-078-37, 37000-078-40, 37000-078-61, 37000-078-70, 37000-078-83, 37000-078-95
- 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
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
- Inactive ingredients
- Questions (or comments)?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 370 mL Bottle Label
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INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS GREEN APPLE 2IN1
pyrithione zinc lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-078 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 FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 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) DIMETHICONE (UNII: 92RU3N3Y1O) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM BENZOATE (UNII: OJ245FE5EU) MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-078-70 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/13/2013 12/01/2024 2 NDC:37000-078-40 400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/13/2013 12/01/2024 3 NDC:37000-078-25 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/13/2013 01/23/2021 4 NDC:37000-078-01 1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/13/2013 09/28/2018 5 NDC:37000-078-11 1180 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/13/2013 03/31/2019 6 NDC:37000-078-95 950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/01/2016 12/01/2024 7 NDC:37000-078-12 1280 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/17/2017 8 NDC:37000-078-02 2 in 1 CELLO PACK 01/01/2021 8 950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 9 NDC:37000-078-37 370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2022 10 NDC:37000-078-61 613 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2022 11 NDC:37000-078-83 835 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)