Label: HEAD AND SHOULDERS TEA TREE OIL 2IN1- pyrithione zinc lotion/shampoo
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NDC Code(s):
69423-417-12,
69423-417-37,
69423-417-40,
69423-417-83, view more69423-417-95
- 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 April 4, 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 lauryl sulfate, glycol distearate, zinc carbonate, sodium chloride, fragrance, cocamidopropyl betaine, sodium xylenesulfonate, dimethicone, menthol, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, sodium laureth sulfate, mentha piperita (peppermint) flower/leaf/stem oil, mentha arvensis leaf/stem oil, melaleuca alternifolia (tea tree) leaf oil, yellow 5, blue 1
- Questions (or comments)?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 370 mL Bottle Label
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INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS TEA TREE OIL 2IN1
pyrithione zinc lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-417 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 MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) TEA TREE OIL (UNII: VIF565UC2G) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) GLYCOL DISTEARATE (UNII: 13W7MDN21W) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) ZINC CARBONATE (UNII: EQR32Y7H0M) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM XYLENESULFONATE (UNII: G4LZF950UR) DIMETHICONE (UNII: 92RU3N3Y1O) 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) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) PEPPERMINT OIL (UNII: AV092KU4JH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69423-417-40 400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/21/2019 12/01/2024 2 NDC:69423-417-95 950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/21/2019 11/01/2024 3 NDC:69423-417-12 1280 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/15/2021 05/01/2023 4 NDC:69423-417-37 370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2022 5 NDC:69423-417-83 835 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 11/21/2019 Labeler - The Procter & Gamble Manufacturing Company (004238200)