Antibacterial Hand Sanitizer

Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Calego International Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL HAND SANITIZER- 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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Antibacterial Hand Sanitizer

Drug Facts

Active ingredient

Alcohol 75% v/v

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin.

Warnings

For external use only. Flammble.

Keep away from heat or flame.

Do not use

  • on children less than 24 months of age
  • on open skin wounds

When using this product

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

Stop use and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

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

Directions

  • Put enough gel in your palm to cover hands and rub hands together rapidly until dry.
  • Children under 6 years of age should be supervised when using this product.

Other information

  • Store between 15-30C (59-86F)
  •  Avoid freezing and excessive heat above 35C(95F)

Inactive ingredients

Aqua, Carbomer, Triethanolamine

Package Labeling:

Label

ANTIBACTERIAL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 72487-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 72487-009-0030 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/202009/28/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/202009/28/2022
Labeler - Calego International Inc. (081320445)

Revised: 9/2022
Document Id: e9d35170-664c-50d6-e053-2995a90a3ad1
Set id: 0991799d-38a4-41f3-85b0-9ecfe1ae368c
Version: 3
Effective Time: 20220929