Label: CAREONE MEDICATED DANDRUFF WITH MENTHOL- selenium sulfide shampoo
-
Contains inactivated NDC Code(s)
NDC Code(s): 41520-718-11 - Packager: American Sales 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, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- 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 Aluminum Silicate, Hydroxypropyl Methylcelllulose, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).
- Questions or comments?
- Label Copy
-
INGREDIENTS AND APPEARANCE
CAREONE MEDICATED DANDRUFF WITH MENTHOL
selenium sulfide shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-718 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 WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) AMMONIUM CHLORIDE (UNII: 01Q9PC255D) MENTHOL (UNII: L7T10EIP3A) SODIUM HYDROXIDE (UNII: 55X04QC32I) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) HYPROMELLOSES (UNII: 3NXW29V3WO) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-718-11 325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/27/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 03/27/2018 Labeler - American Sales Company (809183973) Registrant - Apollo Health and Beauty Care Inc. (201901209) Establishment Name Address ID/FEI Business Operations Apollo Health and Beauty Care Inc. 201901209 manufacture(41520-718)