Label: HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1- pyrithione zinc lotion/shampoo
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NDC Code(s):
37000-095-12,
37000-095-20,
37000-095-25,
37000-095-37, view more37000-095-38, 37000-095-40, 37000-095-61, 37000-095-65, 37000-095-70, 37000-095-83, 37000-095-93, 37000-095-95
- 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 March 30, 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, sodium chloride, 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 - 380 mL Bottle Label
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INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1
pyrithione zinc lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-095 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) POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS) 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) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) SODIUM BENZOATE (UNII: OJ245FE5EU) MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-095-20 200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2013 01/02/2017 2 NDC:37000-095-70 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2013 11/10/2019 3 NDC:37000-095-40 400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/14/2014 11/10/2019 4 NDC:37000-095-25 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/14/2014 03/01/2021 5 NDC:37000-095-95 950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 12/01/2016 11/10/2019 6 NDC:37000-095-38 380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/11/2017 01/15/2025 7 NDC:37000-095-65 650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/11/2017 01/15/2025 8 NDC:37000-095-93 930 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/11/2017 01/15/2025 9 NDC:37000-095-12 1280 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/29/2020 01/15/2025 10 NDC:37000-095-37 370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/15/2023 11 NDC:37000-095-61 613 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/15/2023 12 NDC:37000-095-83 835 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/15/2023 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)