CAREONE MOISTURIZING DANDRUFF- 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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Active Ingredient

Selenium Sulfide 1%

Purpose

Anti-Dandruff

Uses

Controls flaking, scaling and itching associated with dandruff.

Warnings

For external use only

Do not use

  • on scalp that is broken or inflamed
  • if you are allergic to ingredients in this product

When using this product

avoid contact with eyes. If product gets into eyes, rinse eyes thoroughly with water.

Stop using this product 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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Questions? Comments?

1 - 877 - 932 - 7948

Inactive Ingredients

Water (Aqua), Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Dihydrogenated Tallow Phthalic Acid Amide, Cocamide DEA, Fragrance (Parfum), Titanium Dioxide, Dimethicone, Hydroxypropyl Methylcellulose, Citric Acid, Sodium Isostearoyl Lactylate, DMDM Hydantoin, Aloe Barbadensis Leaf Juice, Sodium Citrate, Sodium Chloride, Blue 1 (CI 42090)

Front and Back Labels

image of label

CAREONE  MOISTURIZING DANDRUFF
selenium sulfide shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-611
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM - UNII:H6241UJ22B) SELENIUM SULFIDE1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE (UNII: 1R81RPY10G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-611-11325 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H08/19/2011
Labeler - American Sales Company (809183973)
Registrant - Apollo Health and Beauty Care (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care201901209manufacture

Revised: 8/2011
Document Id: 9cf5a337-e1cc-4db7-b8bf-974eb5dad658
Set id: 7498ba49-9ec8-4057-845b-94e2320870b2
Version: 2
Effective Time: 20110819
 
American Sales Company