315 HAND SANITIZER- ethyl 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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Hand Sanitizer Gel

Active Ingredient(s)

Alcohol 74% 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

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.

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

distilled water, glycerin, propylene glycol, gelling agent, triethanolamine

Package Label - Principal Display Panel

GALLON LABEL 3785 mL NDC: 74262-311-13

315 HAND SANITIZER
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74262-311
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	73.7 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)	0.25 mL in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.05 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	3 mL in 100 mL
PROPANEDIOL (UNII: 5965N8W85T)	3 mL in 100 mL
WATER (UNII: 059QF0KO0R)	20 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74262-311-13	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/02/2020	12/31/2020

Labeler - JAMESTOWN PAINT COMPANY (004323788)

Registrant - JAMESTOWN PAINT COMPANY (004323788)

Name	Address	ID/FEI	Business Operations
Establishment
JAMESTOWN PAINT COMPANY		004323788	manufacture(74262-311)

Revised: 7/2021

Document Id: c82f085d-ac97-2207-e053-2a95a90a2011

Set id: a45fbf09-c448-5915-e053-2a95a90afd47

Version: 2

Effective Time: 20210728

JAMESTOWN PAINT COMPANY