Label: HEAD AND SHOULDERS COCONUT 2IN1- pyrithione zinc shampoo
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NDC Code(s):
69423-316-01,
69423-316-37,
69423-316-40,
69423-316-70, view more69423-316-83, 69423-316-95
- 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 28, 2023
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- 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, zea mays (corn) silk extract, cocos nucifera (coconut) fruit extract, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, yellow5, red 33, blue 1
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 370 mL Bottle Label
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INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS COCONUT 2IN1
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-316 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) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) CORN SILK (UNII: 7D3VB244UX) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 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) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BENZOATE (UNII: OJ245FE5EU) MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4) COCONUT (UNII: 3RT3536DHY) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) D&C RED NO. 33 (UNII: 9DBA0SBB0L) DIMETHICONOL (50000 CST) (UNII: R2285D73YT) 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:69423-316-40 400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/29/2018 11/10/2024 2 NDC:69423-316-70 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/29/2018 11/10/2024 3 NDC:69423-316-95 950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/21/2019 11/10/2024 4 NDC:69423-316-01 2 in 1 CELLO PACK 05/01/2020 11/10/2024 4 950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 5 NDC:69423-316-37 370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2023 6 NDC:69423-316-83 835 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M032 11/29/2018 Labeler - The Procter & Gamble Manufacturing Company (004238200)