Label: HEAD AND SHOULDERS MEN ADVANCED SERIES BOURBON 2IN1- pyrithione zinc lotion/shampoo
- NDC Code(s): 69423-412-37, 69423-412-38, 69423-412-83, 69423-412-93
- 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 28, 2023
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- SPL UNCLASSIFIED SECTION
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- PRINCIPAL DISPLAY PANEL - 370 mL Bottle Label
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INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS MEN ADVANCED SERIES BOURBON 2IN1
pyrithione zinc lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-412 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 DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) D&C RED NO. 33 (UNII: 9DBA0SBB0L) 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) SODIUM BENZOATE (UNII: OJ245FE5EU) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69423-412-38 380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/21/2019 01/01/2025 2 NDC:69423-412-93 930 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 12/01/2021 01/01/2025 3 NDC:69423-412-37 370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/30/2022 4 NDC:69423-412-83 835 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/30/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M032 11/21/2019 Labeler - The Procter & Gamble Manufacturing Company (004238200)