ProLab Scented Hand Sanitizer Gel

ProLab Scented Hand Sanitizer by

Drug Labeling and Warnings

ProLab Scented Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Prolab Health & Beauty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROLAB SCENTED HAND SANITIZER- alcohol gel 
Prolab Health & Beauty Ltd

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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ProLab Scented Hand Sanitizer Gel

ProLab Scented Hand Sanitizer Gel

Drug Facts

Active ingredient

Alcohol 65% v/v

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame.

When using this product

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Do not use

Do not use

  • in children less than 2 months of age
  • on open skin wounds

Keep out of reach of children

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

Directions

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive ingredients

Aloe barbadensis extract, Purified water, Aminomethyl Propanol, Carbomer, Glycerin, Polysorbate 20, Fragrance

Package Label - Principal Display Panel

Made in Canada

Label

Label

PROLAB SCENTED HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77101-9000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
ALOE (UNII: V5VD430YW9)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77101-9000-03785 mL in 1 JUG; Type 0: Not a Combination Product07/24/202012/31/2020
2NDC: 77101-9000-660 mL in 1 TUBE; Type 0: Not a Combination Product07/24/202012/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/24/202012/31/2020
Labeler - Prolab Health & Beauty Ltd (259329733)
Establishment
NameAddressID/FEIBusiness Operations
Prolab Health & Beauty Ltd259329733manufacture(77101-9000)

Revised: 8/2021
Document Id: c9b2925e-1ed5-1e00-e053-2995a90a4e70
Set id: ab79b86d-34f4-167e-e053-2995a90a5e9c
Version: 2
Effective Time: 20210816