ANTIBACTERIAL GEL- alcohol gel 
Evolve Verde, S.A. 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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Antibacterial Gel

Drug Facts

Active ingredient[s]

Ethyl Alcohol Antiseptic 70%

Purpose

   Antiseptic

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use 

  • in children less than 2 months of age
  • on open skin wounds

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

glycerin, Triethanolamine, Propylene Glycol, Aloe Vera extract, Carbomer and water bidistilled

Package Labeling: (78157-000-01)

Label

Package Labeling: (78157-000-02)

Label2

Package Labeling: (78157-000-03)

Label3

ANTIBACTERIAL GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78157-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78157-000-013785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product05/21/2020
2NDC:78157-000-02208198 mL in 1 DRUM; Type 0: Not a Combination Product05/21/2020
3NDC:78157-000-031040000 mL in 1 TANK; Type 0: Not a Combination Product05/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/21/2020
Labeler - Evolve Verde, S.A. de C.V. (812855156)
Establishment
NameAddressID/FEIBusiness Operations
Evolve Verde, S.A. de C.V.812855156manufacture(78157-000)

Revised: 5/2020
Document Id: a68a8e14-5747-d9d9-e053-2a95a90a200b
Set id: 12bed13b-97fa-41f5-ac35-bda40af96e48
Version: 1
Effective Time: 20200526
 
Evolve Verde, S.A. de C.V.