HAND SANITIZER- alcohol solution 
Bluebonnet Petrochemical Solutions

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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HAND SANITIZER, ALCOHOL ANTISEPTIC 80%, ANTISEPTIC HAND RUB NON-STERILE SOLUTION,ecowerks.com, bps-us.com, 1 Gallon (3785 mL)

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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

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.

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

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

HAND SANITIZER - ALCOHOL ANTISEPTIC 80%

ANTISEPTIC HAND RUB NON-STERILE SOLUTION

3785 mL NDC: 75339-801-01

label image

HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75339-801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75339-801-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
2NDC:75339-801-021597 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
3NDC:75339-801-04236.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
4NDC:75339-801-03473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Bluebonnet Petrochemical Solutions (832103001)
Registrant - Bluebonnet Petrochemical Solutions (832103001)
Establishment
NameAddressID/FEIBusiness Operations
Bluebonnet Petrochemical Solutions832103001manufacture(75339-801)

Revised: 4/2020
Document Id: a34ccf1e-69ca-4fd3-e053-2a95a90a473e
Set id: a34cd039-588f-296e-e053-2a95a90a66f7
Version: 1
Effective Time: 20200414
 
Bluebonnet Petrochemical Solutions