Lifebuoy Hand Sanitizer - 70% Alcohol

Lifebuoy Hand Sanitizer by

Drug Labeling and Warnings

Lifebuoy Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by MILOTT LABORATORIES COMPANY LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LIFEBUOY HAND SANITIZER 70 PERCENT- alcohol gel 
MILOTT LABORATORIES COMPANY LIMITED

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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Lifebuoy Hand Sanitizer - 70% Alcohol

ACTIVE INGREDIENT

Alcohol 70% 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.


Do Not Use

  • On children less than 2 months of age
  • On open skin wounds.

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

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

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

Purified Water USP, Carbomer, Propylene Glycol, Aminomethyl Propanol, PEG-12 Dimethicone, Disodium EDTA, Aloe Barbadensis Extract, Maltodextrin, Potassium Sorbate, Sodium Benzoate

OTHER INFORMATION

  • Store between 15-30℃ (59-86℉)
  • Avoid freezing and excessive heat above 40℃ (104℉)

01b LBL_LB_HandSanitizer_Milott_Tube_50ml_FDA_OL

LIFEBUOY HAND SANITIZER  70 PERCENT
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 12541-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 12541-102-1150 mL in 1 TUBE; Type 0: Not a Combination Product06/04/2020
2NDC: 12541-102-12445 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/04/2020
Labeler - MILOTT LABORATORIES COMPANY LIMITED (659931018)

Revised: 6/2020
Document Id: 50ae426b-189f-41cd-a20d-6e7151a81970
Set id: f1d0ec43-5630-4f02-bb8e-6a925fc72f5b
Version: 3
Effective Time: 20200618