Label: CAREONE MEDICATED DANDRUFF- selenium sulfide shampoo
- NDC Code(s): 72476-025-03
- Packager: Retail Business Services, LLC
- 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 November 22, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other Information
-
Inactive Ingredients
Water (Aqua), Sodium Laureth Sulfate, TEA-Lauryl Sulfate, Cocamidopropyl Betaine, Acrylates Copolymer, Citric Acid, Fragrance (Parfum), Ammonium Chloride, Menthol, Sodium Hydroxide, Magnesium Aluminium Silicate, Hydroxypropyl Methylcellulose, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (Cl 42090), Red 33 (Cl 17200).
- Questions or comments ?
- PDP03
-
INGREDIENTS AND APPEARANCE
CAREONE MEDICATED DANDRUFF
selenium sulfide shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72476-025 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM LAURETH SULFATE (UNII: BPV390UAP0) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MENTHOL (UNII: L7T10EIP3A) SODIUM HYDROXIDE (UNII: 55X04QC32I) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C RED NO. 33 (UNII: 9DBA0SBB0L) WATER (UNII: 059QF0KO0R) TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) AMMONIUM CHLORIDE (UNII: 01Q9PC255D) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72476-025-03 325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/26/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 08/26/2021 Labeler - Retail Business Services, LLC (967989935) Registrant - Apollo Health and Beauty Care (201901209) Establishment Name Address ID/FEI Business Operations Apollo Health and Beauty Care 201901209 manufacture(72476-025)