108 HAND SANITIZER- isopropyl alcohol liquid 
JAMESTOWN PAINT COMPANY

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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This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only USP grade ingredients in the preparation of the product, consistent with World Health Organization (WHO) recommendations.

The firm does not add other active or inactive ingredients.

Active Ingredient(s)

Active Ingredients: Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose and Use:

Antiseptic, Hand Sanitizer, Non-Sterile; Hand Sanitizer to 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 59°-86°F
  • Avoid freezing and excessive heat above 104°F

Inactive ingredients

glycerin, hydrogen peroxide, distilled water USP

Package Label - Principal Display Panel

3785 ml NDC: 74262-310-12

PINT LABEL

108 HAND SANITIZER 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74262-310
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 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:74262-310-12475 mL in 1 JAR; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/202012/31/2020
Labeler - JAMESTOWN PAINT COMPANY (004323788)
Registrant - JAMESTOWN PAINT COMPANY (004323788)
Establishment
NameAddressID/FEIBusiness Operations
JAMESTOWN PAINT COMPANY004323788manufacture(74262-310)

Revised: 7/2021
 
JAMESTOWN PAINT COMPANY