TOPCARE ADVANCED HAND SANITIZER 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.

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Drug Facts 

Active ingredient

Ethyl Alchol 70%

Purpose

Antiseptic

Uses

to help reduce bacteria on the skin

Warnings

For external use only

When using this product 

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Sto use and ask a doctor if

irritation or redness develops and lasts.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately. 1-800-222-1222

Directions

Other information

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Propylene Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum), Ethylhexylglycerin, Yellow 5 (CI 19140), Blue 1 (CI 42090).

Label copy

Image of the label

Image of the label 8oz

TOPCARE ADVANCED HAND SANITIZER  ALOE
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-995
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)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CARBOMER 934 (UNII: Z135WT9208)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-995-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/2019
2NDC:36800-995-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/20/2019
Labeler - TopCo Associates LLC (006935977)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(36800-995)

Revised: 8/2019
Document Id: 1969937c-4b9a-4e9a-a41c-56fb27a12fe5
Set id: 79f8d94e-839d-495f-b06c-1af2213f6ffe
Version: 1
Effective Time: 20190821
 
TopCo Associates LLC