CAREONE MOISTURIZING DANDRUFF- 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

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 IF YOU HAVE

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP

WHEN USING THIS PRODUCT

  • AVOID CONTACT WITH 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

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, DISTEARYL PHTHALIC ACID AMIDE, SODIUM CHLORIDE, COCAMDIOPROPYL BETAINE, SODIUM STEAROYL LACTYLATE, DIMETHICONE, DMDM HYDANTOIN, CITRIC ACID, FRAGRANCE (PARFUM), SODIUM HYDROXIDE, SODIUM CITRATE, ALOE BARBADENSIS LEAF JUICE, HYDROXYPROPYL METHYLCELLULOSE, TITANIUM DIOXIDE, BLUE 1 (CI 42090)

LABEL COPY

IMAGE OF THE LABEL

CAREONE  MOISTURIZING DANDRUFF
selenium sulfide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-622
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)  
DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-622-11325 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/13/2015
Labeler - AMERICAN SALES COMPANY (809183973)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(41520-622)

Revised: 1/2015
Document Id: fa64738e-65a2-4267-b5bf-51c783b28c80
Set id: 1d4783af-1384-40cf-9980-7188bd38291e
Version: 1
Effective Time: 20150114
 
AMERICAN SALES COMPANY