WOUND CLEANSER- wound cleanser spray

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)
Available from:
Dynarex Corporation
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
First aid to help prevent infection in minor cuts, scrapes and burns. Do not use - in the eyes or over large areas of the body. - longer than 1 week unless directed by a doctor Stop use and consult a doctor if - if condition persists or gets worse. Mild non-irritating wound cleanser for removing exudates and debris in wounds
Authorization status:
OTC monograph not final
Authorization number:
67777-403-01

WOUND CLEANSER- wound cleanser spray

Dynarex Corporation

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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3005 DynaWound Wound Cleanser Spray NDC 67777-403-01

Active ingredient Purpose

Benzethonium chloride 0.13% v/v First aid antiseptic

Us e

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

Warnings

For External Use Only

Do not use

in the eyes or over large areas of the body.

longer than 1 week unless directed by a 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

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

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

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.

Dynarex Wound Cleanser

Item 3005

3005 Wound.jpg

WOUND CLEANSER

wound cleanser spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 7777-40 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZETHO NIUM CHLO RIDE (UNII: PH41D0 5744) (BENZETHONIUM -

UNII:1VU15B70 BP)

BENZETHONIUM

CHLORIDE

1.3 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Dynarex Corporation

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYQ UATERNIUM-10 ( 12 5 MPA.S AT 2 %) (UNII: L45WU8 S9 8 1)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 7777-40 3-

214 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

0 2/13/20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 2/13/20 17

Labeler -

Dynarex Corporation (008124539)

Registrant -

Dynarex Corporation (008124539)

Revised: 3/2019

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