HAND SANITIZER- alcohol gel 
GIA EVOLUTION SA DE CV

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(s)

Alcohol 72% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

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.

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

purified water USP, glycerin, carbomer, triethanolamine, vitamin E.

Package Label - Principal Display Panel

200000 mL NDC: 77231-030-01 200 L

1000000 mL NDC: 77231-030-02 1000L

20000000 mL NDC: 77231-030-03 Tank

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77231-030
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
TOCOPHEROL (UNII: R0ZB2556P8) 0.02 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 1.5 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.5 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 1 g  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77231-030-01200000 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
2NDC:77231-030-021000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
3NDC:77231-030-0320000000 mL in 1 TANK; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - GIA EVOLUTION SA DE CV (951577293)
Registrant - GIA EVOLUTION SA DE CV (951577293)
Establishment
NameAddressID/FEIBusiness Operations
GIA EVOLUTION SA DE CV951577293manufacture(77231-030) , pack(77231-030) , label(77231-030)

Revised: 6/2020
Document Id: a7c5233c-2dd2-72eb-e053-2a95a90a2509
Set id: a6182adf-f251-0802-e053-2a95a90a9abc
Version: 3
Effective Time: 20200610
 
GIA EVOLUTION SA DE CV