DELISTED - Hand Santiizer (80083-001)

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

HAND SANITIZER- alcohol liquid 
Pristine 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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DELISTED - Hand Santiizer (80083-001)

Active Ingredient(s)

Alcohol 80% v/vAlcohol 80% v/v..................... Purpose: Antiseptic

Purpose

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

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 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
    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 When using product

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

Keep out of reach of childrenKeep 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.

Other information

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

Inactive ingredients

Inactive Ingredientsglycerin, hydrogen peroxide, purified water USP, Peppermint CF0037800

Package Label - Principal Display Panel

Principal Pannel

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80083-001
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) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
PEPPERMINT OIL (UNII: AV092KU4JH) 0.0645 g  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80083-001-01120 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/04/2020
2NDC: 80083-001-03100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/04/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/04/202005/19/2022
Labeler - Pristine LLC (117619238)
Registrant - Pristine LLC (117619238)

Revised: 5/2021
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Trademark Results [Hand Sanitizer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HAND SANITIZER
HAND SANITIZER
88958909 not registered Live/Pending
MAISON BLANCHE, LLC
2020-06-10

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