CARE ONE ANTIBACTERIAL RUM RAISIN- ethyl alcohol lipstick 
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

ETHYL ALCOHOL 65%

PURPOSE

ANTISEPTIC

USES

TO DECREASE BACTERIA ON THE SKIN.

WARNINGS

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE.

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

OTHER INFORMATION

STORE AT A TEMPERATURE BELOW 110F (43C).

INACTIVE INGREDIENTS:

WATER (AQUA), ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), PROPYLENE GLYCOL, BENZOPHENONE-4, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, TOCOPHERYL ACETATE, CARAMEL.

IMAGE OF THE LABEL

CARE ONE  ANTIBACTERIAL RUM RAISIN
ethyl alcohol lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-469
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER 934 (UNII: Z135WT9208)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SULISOBENZONE (UNII: 1W6L629B4K)  
MANNITOL (UNII: 3OWL53L36A)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARAMEL (UNII: T9D99G2B1R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-469-0259 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/25/2012
Labeler - AMERICAN SALES COMPANY (809183973)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(41520-469)

Revised: 9/2012
Document Id: 8c4193a3-a200-4c78-aafc-7a0b702c09c9
Set id: 72b40b4e-60ec-46a7-bb27-44249d95c511
Version: 1
Effective Time: 20120926
 
AMERICAN SALES COMPANY