HAND SANITIZER- alcohol gel 
Brands International

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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Germs Be Gone Hand sanitizers

Drug Facts

Active Ingredient

Ethyl Alcohol, 66% w/w (73%, v/v)

Purpose

Antiseptic

Uses

instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

Warnings

For external use only. Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

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

Directions

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Other Information

Store below 43°C (110°F)

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, denatonium benzoate, disodium EDTA, glycerin, PEG-40 castor oil, propylene glycol, water, isopropyl myristate.

Please see label on the container.

Germsbegone

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL66 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50157-500-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/19/2020
Labeler - Brands International (243748238)

Revised: 3/2020
Document Id: a138f493-7ab6-eb44-e053-2a95a90a9276
Set id: a138f501-8acb-ec18-e053-2a95a90ad451
Version: 6
Effective Time: 20200319
 
Brands International