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Assured Aloe by 4E Global, S.A.P.I. de C.V

Dosage form: gel
Ingredients: ALCOHOL 70mL in 100mL
Labeler: 4E Global, S.A.P.I. de C.V
NDC Code: 60599-999

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.

Active Ingredient Purpose

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

Uses

  • for handwashing to decrease bacteria on the skin
  • recommended for repeated use

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

  • wet hands thoroughly with product
  • briskly rub hands together until dry
  • supervise children under 6 years in the use of this product

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

ASSURED ALOE 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60599-999
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CARBOMER COPOLYMER TYPE A 
TROLAMINE 
GLYCERIN 
PROPYLENE GLYCOL 
ALOE VERA LEAF 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:60599-999-10295 mL in 1 BOTTLE
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/FEIOperations
4E Global, S.A.P.I. de C.V812821307manufacture(60599-999)

Revised: 02/2018
 
4E Global, S.A.P.I. de C.V

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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