HAND SANITIZER- alcohol liquid

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Emergency Medical Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Alcohol 75% 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

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

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

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

Water

Triethanolamine

Carbomer Homopolymer

Package label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76885-003(NDC:55467-002)
Route of Administration	EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	375 mL  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	2 mL  in 500 mL
TROLAMINE (UNII: 9O3K93S3TK)	1.5 mL  in 500 mL
WATER (UNII: 059QF0KO0R)	121.5 mL  in 500 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code	THOMSON
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76885-003-11	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2020
2	NDC: 76885-003-08	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/30/2020

Labeler - Emergency Medical Solutions LLC (117478411)

Establishment
Name	Address	ID/FEI	Business Operations
Emergency Medical Solutions LLC		117478411	relabel(76885-003)