Label: HEAD AND SHOULDERS CLINICAL STRENGTH- selenium sulfide lotion/shampoo
- NDC Code(s): 37000-330-01, 37000-330-40, 37000-330-70
- 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 January 20, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
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Inactive ingredients
Water, ammonium laureth sulfate, ammonium lauryl sulfate, glycol distearate, cocamide MEA, ammonium xylenesulfonate, sodium citrate, fragrance, dimethicone, cetyl alcohol, sodium chloride, citric acid, sodium benzoate, stearyl alcohol, sisodiumEDTA, sodium laureth sulfate, hydroxypropyl methylcellulose, camphor, eucalyptol, methylchloroisothiazolinone, methylisothiazolinone, red 4.
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label
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INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS CLINICAL STRENGTH
selenium sulfide lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-330 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) EUCALYPTOL (UNII: RV6J6604TK) AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN) WATER (UNII: 059QF0KO0R) AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B) GLYCOL DISTEARATE (UNII: 13W7MDN21W) COCO MONOETHANOLAMIDE (UNII: C80684146D) AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM) SODIUM CITRATE (UNII: 1Q73Q2JULR) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) SODIUM CHLORIDE (UNII: 451W47IQ8X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C RED NO. 4 (UNII: X3W0AM1JLX) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) Product Characteristics Color orange Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-330-40 400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2010 11/19/2022 2 NDC:37000-330-70 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/13/2017 10/22/2022 3 NDC:37000-330-01 2 in 1 CELLO PACK 11/09/2018 10/22/2022 3 400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 07/01/2010 11/19/2022 Labeler - The Procter & Gamble Manufacturing Company (004238200)