ASSURED ALOE- ethyl alcohol gel 
4E Global, S.A.P.I. de C.V

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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Active Ingredient Purpose

Ethyl Alcohol 70.0% v/v..................... Antimicrobial

Uses

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Kills 99% of germs!

Aloe Vera & Moisturizers

Directions

Warnings

For external use only.

Flammable, keep away from heat and flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Inactive Ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, fd&c blue no. 1, fd&c yellow no. 5.

Product Label

aloevera

ASSURED ALOE 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60599-999
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60599-999-10295 mL in 1 BOTTLE; Type 0: Not a Combination Product10/27/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/27/2017
Labeler - 4E Global, S.A.P.I. de C.V (812821307)
Establishment
NameAddressID/FEIBusiness Operations
4E Global, S.A.P.I. de C.V812821307manufacture(60599-999)

Revised: 2/2018
Document Id: 6bf44095-4ff0-4ed2-b7be-4e7d48f92131
Set id: d2770440-3d43-4481-ac2b-45b8210ee62f
Version: 2
Effective Time: 20180201
 
4E Global, S.A.P.I. de C.V