FOAMING ALCOHOL HAND SANITIZER- ethyl alcohol solution 
Global Equipment Company

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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Global Equipment F688F

Active Ingredient - Ethyl Alcohol 62% v/v

Purpose - Antbacterial Agent

Uses - Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Warnings

For external use only.

Flammable. Keep away from heat or flames.

Avoid contact with eyes. If eye contact occurs, flush with water.

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

Directions

Apply small amount to palm. Briskly rub, covering hands with product until dry.

Inactive Ingredients - Water, PEG-10 Dimethicone, Glycerin, Isopropyl Myristate, Polyquaternium-11, Disodium EDTA, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.

Primary Label

FOAMING ALCOHOL HAND SANITIZER 
ethyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78641-688
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DISODIUM EDTA-COPPER CU-64 (UNII: 4J875U5U11)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78641-688-78950 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/2020
2NDC:78641-688-501200 mL in 1 BAG; Type 0: Not a Combination Product03/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/16/2020
Labeler - Global Equipment Company (001472216)
Registrant - Kutol Products Company (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company004236139manufacture(78641-688)

Revised: 8/2023
Document Id: 03a8fa2d-97ad-9f63-e063-6394a90afe68
Set id: a7342b24-eecf-47a7-e053-2a95a90af9ed
Version: 3
Effective Time: 20230824
 
Global Equipment Company