Wound Cleanser by Dynarex Corporation WOUND CLEANSER spray

Wound Cleanser by

Drug Labeling and Warnings

Wound Cleanser by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                               Purpose

Benzethonium chloride 0.13%  v/v                    First aid antiseptic

Use

First aid to help prevent infection in minor cuts, scrapes and burns.

Warnings

For External Use Only

DO NOT USE

Do not use

• in the eyes or over large areas of the body.
• longer than 1 week unless directed by a doctor

ASK DOCTOR

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

Stop use

Stop use and consult a doctor if

• if condition persists or gets worse.

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.

INDICATIONS & USAGE

Mild non-irritating wound cleanser for removing exudates and debris in wounds

DOSAGE & ADMINISTRATION

Directions

• Clean the affected area
• Spray a small amount of this product on the area 1 to 3 times daily
• May be covered with a sterile bandage
• If bandaged let dry first

Other

Other information

• Store at room temperature
• Avoid excessive heat

Inactive ingredients

Inactive ingredients: Benzyl alcohol, Edetate disodium, Glycerin, Polyquaternium 10, Polysorbate 20, Purified water, Sodium citrate.

PRINCIPAL DISPLAY PANEL

Dynarex Wound Cleanser

Item 3005

3005 Wound.jpg

INGREDIENTS AND APPEARANCE

WOUND CLEANSER 
wound cleanser spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-403
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-403-01	214 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/13/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/13/2017

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)