ANTISEPTIC HAND SANITIZER MIST by Bayport Laboratories Corporation HAND SANITIZER

ANTISEPTIC HAND SANITIZER MIST by

Drug Labeling and Warnings

ANTISEPTIC HAND SANITIZER MIST by is a Otc medication manufactured, distributed, or labeled by Bayport Laboratories Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTISEPTIC HAND SANITIZER MIST- alcohol solution 
Bayport Laboratories Corporation

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

Active Ingredient(s)

Alcohol 80% 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

  • 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

Hand Sanitizer_1 gallon (06-2020) BPL

Hand Sanitizer_250 mL (06-2020) BPL

Hand Sanitizer_500 mL (06-2020) BPL

ANTISEPTIC HAND SANITIZER MIST 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75175-001
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)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75175-001-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/21/202012/28/2020
2NDC: 75175-001-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/21/202012/28/2020
3NDC: 75175-001-033785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/21/202012/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/21/202012/28/2020
Labeler - Bayport Laboratories Corporation (053023422)
Establishment
NameAddressID/FEIBusiness Operations
Bayport Laboratories Corporation053023422manufacture(75175-001)

Revised: 12/2020
Document Id: e2379d19-1ddb-47d6-b559-41b00ec0af2a
Set id: ebea02ef-96aa-4a6b-a94a-f432dbe92ffe
Version: 2
Effective Time: 20201228