ANTIMICROBIAL HAND- alcohol gel 
Calego International Inc.

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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Antimicrobial Hand Gel

Drug Facts

Active ingredient

Ethyl Alcohol 70% w/w

Purpose

Antimicrobial

Use

hand sanitizer to help reduce microbes on the skin

Warnings

Flammable. Keep away from fire or flame

For external use only.

When using this product,

do not use in or near the eyes. If contact occurs, rinse thoroughly with water

Stop use and ask a doctor

if irritation and redness develops and persists for more than 72 hours and continues

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

carbomer, fragrance, glycerin, propylene glycol, silicone, triethanolamine, water (aqua)

Package Labeling:

Bottle60ml

ANTIMICROBIAL HAND 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72487-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72487-008-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/2020
Labeler - Calego International Inc. (081320445)

Revised: 5/2020
Document Id: a59994c8-6884-378e-e053-2a95a90af92b
Set id: f52f07f7-0ed5-493a-b5e0-d5d45027f94a
Version: 1
Effective Time: 20200514
 
Calego International Inc.