CAREONE MEDICATED DANDRUFF WITH MENTHOL- selenium sulfide shampoo 
American Sales Company

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.

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Drug Facts

Active ingredient

Selenium Sulfide 1%

Purpose

Anti-dandruff, anti-seborrheic dermatitis

Uses

for the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help preve the chance of recurrence.

Warnings

For external use only.

Ask a doctor before use if

you have seborrheic dermatitis in areas other than the scalp.

When using this product

  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • for use on color treated or permed hair, rinse thoroughly.

Stop use and ask a doctor if

condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

Other information

store at room temperature.

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?

1-877-846-9949

Label Copy

Image of the label

CAREONE MEDICATED DANDRUFF WITH MENTHOL 
selenium sulfide shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-718
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-718-11325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H03/27/2018
Labeler - American Sales Company (809183973)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(41520-718)

Revised: 3/2018
Document Id: cae4c897-c698-4594-a6f4-3a58925c61ea
Set id: 084ed4fb-f95b-4d10-8678-10c3573fee97
Version: 1
Effective Time: 20180328
 
American Sales Company