CARE ONE MEDICATED- selenium sulfide liquid 
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

ANTIDANDRUFF

USE

FOR RELIEF OF FLAKING AND ITCHING DUE TO DANDRUFF, AND SEBORRHEIC DERMATITIS, AND TO HELP PREVENT THE CHANCE OF RECURRENCE.

WARNINGS

FOR EXTERNAL USE ONLY.

ASK A DOCTOR BEFORE USING IF YOU HAVE

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES 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

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

SHAKE WELL. SHAMPOO, THEN RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE.

INACTIVE INGREDIENTS:

WATER (AQUA), SODIUM LAURETH SULFATE, ACRYLATES COPOLYMER, TEA-LAURYL SULFATE, COCAMIDOPROPYL BETAINE, CITRIC ACID, AMMONIUM CHLORIDE, SODIUM HYDROXIDE, DMDM HYDANTOIN, FRAGRANCE (PARFUM), MAGNESIUM ALUMINUM SILICATE, HYDROXYPROPYL METHYLCELLULOSE, MENTHOL, BLUE 1 (CI 42090), RED 33 (CI 17200).

QUESTIONS/COMMENTS?

1-866-695-3030

LABEL COPY

IMAGE OF THE LABEL

CARE ONE  MEDICATED
selenium sulfide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-620
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)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
TEA-LAURYL SULFATE (UNII: E8458C1KAA)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MENTHOL (UNII: L7T10EIP3A)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-620-11325 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H08/15/2013
Labeler - AMERICAN SALES COMPANY (809183973)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(41520-620)

Revised: 7/2013
Document Id: 60ebdc33-d41d-40d5-a5ba-3cb824115c8d
Set id: 8041c081-dcbd-4f47-86a1-e8d609a5a5c3
Version: 1
Effective Time: 20130715
 
AMERICAN SALES COMPANY