Hand Sanitizer by Broder Bros Prime Line Hand Sanitizer Gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Broder Bros Prime Line. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
Broder Bros Prime Line

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

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Uses

for hand sanitizing.

Warnings

Flammable, keep away from fire and flame

For external use only

When using this product

• Keep out of eyes
• In case of contact with eyes, flush thoroughly with water.
• Avoid contact with broken skin.
• Do not inhale or ingest.

Stop use and ask a doctor

Stop use and ask a doctor if irritation and redness develops and persists for more than 72 hours.

Keep our of reach of Children.

If swallowed, get medical help or call a Poison Control Center right away.

Directions

• Wet hands thoroughly with product, brisky rub together until dry.
• Always supervise children in the use of this product.
• Children under the age of 6 months: Ask a doctor.

Other information

• Store at 66 to 77 F (22 to 25 C)
• May discolor some fabrics
• Harmful to wood finishes and platics

Inactive ingredients

Carbomer, Glycerin, Triethanolamine, Water

Questions?

1-800-873-7746

M-F 8am-5pm EST

Package Label - Principal Display Panel

5 mL NDC: 80017-003-01

Hand Sanitizer

Net wt. 5mL/0.17 fl.oz.

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80017-003(NDC: 74742-009)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80017-003-01	5 mL in 1 TUBE; Type 0: Not a Combination Product	10/28/2020	03/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/28/2020	03/05/2021

Labeler - Broder Bros Prime Line (107044246)

Revised: 3/2021

Document Id: bcd89935-bf71-26f5-e053-2a95a90a26bc

34390-5

Set id: b2c9b78c-39bd-eb09-e053-2a95a90ad7cd

Version: 2

Effective Time: 20210306