HAND SANITIZER- ethyl alcohol gel 
Biolab International Incorporated

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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Active ingredients

Ethyl Alcohol 62%

Purpose
Antiseptic

Uses hand sanitizer to help reduce bacteria on the skin . For occassional and personal domestic use

Warnings

for external use only: hands

Flammable. Keep away from fire or flame

when using this product, avoid contact with eyes, in case of contact, rinse eyes thoroughly with water, avoid contact with broken skin .

Stop use and consult a doctor if . irritation or redness develops. condition persists for more than 72 hours

Keep out of reach of children. children under 6, use only under adult supervision, Not recommended for infants.

For external use only. Do not drink.
If swallowed, seek professional assistance or contact a poison control center.

Directions. Place enough product in your palm to thoroughly spread on both hands and rub into skin until dry.

Other information. do not store above 105°F, may discolor some fabics. harmful to wood finished and plastics

Inactive ingredients acrylates/C10-C30 alkyl acrylate crosspolymer,aloe barbadensis leaf juice, glycerin, maltodextrin, propylene glycol, water , triethanolamine,Fragrance. FD&C Red No.4

image of bottle label

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72264-028
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
TROLAMINE (UNII: 9O3K93S3TK)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72264-028-01236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/29/2020
Labeler - Biolab International Incorporated (200167919)

Revised: 6/2020
Document Id: a94a5b1c-902e-1e0a-e053-2995a90a25a7
Set id: a94a5d04-127f-0e89-e053-2a95a90a782c
Version: 1
Effective Time: 20200630
 
Biolab International Incorporated