BAC Hand Sanitizer by PreVasive USA LLC BAC Hand Sanitizer

BAC Hand Sanitizer by

Drug Labeling and Warnings

BAC Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by PreVasive USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BAC HAND SANITIZER- isopropyl alcohol gel 
PreVasive USA LLC

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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BAC Hand Sanitizer

Drug Facts

Active ingredient[s]

Isopropyl alcohol 75% v/v

Purpose

Antiseptic

Use

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

Warnings

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

Do not use

  • in 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 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

  • 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.

Other information

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

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Labeling:500ml

Pic

Package Labeling:3785mL

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Package Labeling:208198 mL

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BAC HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78895-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.75 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78895-000-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/202001/31/2022
2NDC: 78895-000-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/202001/31/2022
3NDC: 78895-000-55208198 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/202001/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/202001/31/2022
Labeler - PreVasive USA LLC (095709896)

Revised: 9/2022
 

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