TOPCARE ALOE- ethyl alcohol liquid 
TOPCO ASSOCIATES 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.

----------

DRUG FACTS

ACTIVE INGREDIENT

ETHYL ALCOHOL 70% V/V

PURPOSE

ANTISEPTIC

USES

TO HELP REDUCE BACTERIA ON THE SKIN.

WARNINGS

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

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

STOP USE AND ASK A DOCTOR IF

IRRITATION OR REDNESS DEVELOP AND LAST.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

PUT ENOUGH PRODUCT IN YOUR PALM TO COVER HANDS AND RUB HANDS TOGETHER UNTIL DRY. CHILDREN UNDER 6 YEARS SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

OTHER INFORMATION

STORE AT A TEMPERATURE BELOW 110F (43C). MAY DISCOLOR SOME FABRICS OR SURFACES.

INACTIVE INGREDIENTS:

WATER (AQUA), ISOPROPYL ALCOHOL, ETHYLHEXYLGLYCERIN, GLYCERIN, ISOPROPYL MYRISTATE, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALOE BARBADENSIS LEAF JUICE, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), BLUE 1 (CI 42090), YELLOW 5 (CI 19140).

QUESTIONS OR COMMENTS?

1-888-423-0139

LABEL COPY

IMAGE OF THE LABEL

TOPCARE  ALOE
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-079
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-079-08237 mL in 1 BOTTLE, PLASTIC07/31/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/31/2013
Labeler - TOPCO ASSOCIATES LLC (006935977)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(36800-079)

Revised: 8/2013
Document Id: 2f625f76-dac6-4450-88bc-f10abc542996
Set id: 18b7530e-5600-459b-bedd-a620f99fbace
Version: 1
Effective Time: 20130802
 
TOPCO ASSOCIATES LLC