CAREONE MEDICATED DANDRUFF- selenium sulfide shampoo 
Retail Business Services, LLC

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 prevent the chance of recurrence.

Warnings

For external use only.

Ask a doctor before use

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 Aluminium Silicate, Hydroxypropyl Methylcellulose, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (Cl 42090), Red 33 (Cl 17200).

Questions or comments ?

1-877-846-9949

PDP03

PDP03

CAREONE MEDICATED DANDRUFF 
selenium sulfide shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-025
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
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    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72476-025-03325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/26/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H08/26/2021
Labeler - Retail Business Services, LLC (967989935)
Registrant - Apollo Health and Beauty Care (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Spa Dent Inc203478896manufacture(72476-025)

Revised: 9/2021
Document Id: cb05b9c6-c1bc-b210-e053-2a95a90afaea
Set id: cb05b9c6-c1bb-b210-e053-2a95a90afaea
Version: 1
Effective Time: 20210902
 
Retail Business Services, LLC