PERFECT LIFE- alcohol gel 
COMERCIAL GOURA,S. DE R.L.

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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HAND SANITIZER GEL DRUM

DOSAGE AND ADMINISTRATION

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

INACTIVE INGREDIENTS

Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine

DIRECTIONS

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

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

KEEP OUT OF REACH OF CHILDREN

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

ACTIVE INGREDIENT

Active ingredient. Ethyl Alcohol 70% v/v

PURPOSE

Purpose Antmicrobial

WARNINGS AND PRECAUTIONS SECTION

Warnings

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

Children under 6 years of age should be supervised when using.

Other information

Store below 110°F (43°C)

WARNINGS

Warnings

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

STOP USE AND ASK A DOCTOR

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

PACKAGE LABEL

DRUM LABEL 200 L

PERFECT LIFE 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78501-2000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 L  in 1 L
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E) 0.002 L  in 1 L
GLYCERIN (UNII: PDC6A3C0OX) 0.0375 L  in 1 L
TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253) 0.002 L  in 1 L
WATER (UNII: 059QF0KO0R) 0.2585 L  in 1 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78501-2000-8200 L in 1 DRUM; Type 0: Not a Combination Product06/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/07/2020
Labeler - COMERCIAL GOURA,S. DE R.L. (951578628)
Registrant - COMERCIAL GOURA,S. DE R.L. (951578628)
Establishment
NameAddressID/FEIBusiness Operations
COMERCIAL GOURA,S. DE R.L.951578628manufacture(78501-2000)

Revised: 6/2020
Document Id: a78a073c-6b0d-201b-e053-2a95a90aa3a6
Set id: a78a073c-6b0c-201b-e053-2a95a90aa3a6
Version: 1
Effective Time: 20200607
 
COMERCIAL GOURA,S. DE R.L.