DERMAWOUND WOUND CARE VENOUS STASIS- benzocaine hydrochloride ointment

DermaWound Wound Care Venous Stasis by

Drug Labeling and Warnings

DermaWound Wound Care Venous Stasis by is a Otc medication manufactured, distributed, or labeled by Progressive Doctors, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzocaine Hydrochloride (1.27%)

Purpose

Local Anesthetic

Uses

topical pain relief of minor

• cuts
• scrapes
• burns

Warnings

For external use only

Do not use

• in the eyes
• if you have methemoglobinemia
• if pregnant or lactating

Ask a doctor before use

in case of deep or puncture wounds, animal bites, or serious burns.

Stop use and ask a doctor if

• the condition persists or gets worse
• irritation or rash appears
• you need to use the product for more than 1 week

Keep Out of Reach of Children

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

Directions

• Gently clean around the affected area
• Prior to application of DermaWound ®, evaluate the wound or ulcer to insure no excessive bleeding is present. Never wipe out the ulcer.
• Apply a moderate amount of DermaWound ® directly to affected area.
• Deeper or "tunneling" wounds may require packing and/or sides coated with additional DermaWound ® and sterile gauze.
• Apply additional sterile gauze to absorb exudates, if needed.
• Change Dressing 2 or 3 times daily or as directed by a physician.
• May require supervision of a health care professional in the management of chronic & acute wound care, pressure sores, diabetic ulcers, surgical wounds & indwelling catheters.

Cautions

• Persons allergic or sensitive to iodine and/or benzocaine should avoid contact with this product.
• Do not restrict circulation when applying DermaWound ® with sterile gauze.
• Apply additional sterile gauze to absorb exudates, if needed.
• Change Dressing 2 or 3 times daily or as directed by a physician.

Other Information

• Store at 59°-86°F (15-30°C)
• Avoid Heat and Direct Sunlight

Inactive ingredients

Sucrose (Poly-saccharide Blend), Calcium Carbonate (Poly-mineral Blend, vegan), Glycerin, Xanthan Gum, PVP-Iodine, Methylparaben, and Deionized Water.

Questions or Comments?

www.DermaWound.com or 1-866-727-0462

Non-irritating, Clinically tested, and Allergy tested.

Certified Green Manufacturing
Contents Biodegradable
Eco-Friendly

Manufactured for and Distributed by Wound Care USA, LLC
Tucson, Arizona 85712

©2014 U.S. & International Patents Pending

Made With Solar Power

Made in U.S.A.
NDC# 57554-120-06

Stir if Separated

Package/Label Principal Display Panel

DermaWound ® Professional Care

Wound Care Local Anesthetic Ointment

Venous Stasis Formula

Net Wt. 6 oz. (179 g)

Carton Label

INGREDIENTS AND APPEARANCE

DERMAWOUND WOUND CARE VENOUS STASIS 
benzocaine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57554-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	1.27 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
CALCIUM CARBONATE (UNII: H0G9379FGK)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)
POVIDONE-IODINE (UNII: 85H0HZU99M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57554-120-06	1 in 1 CARTON	02/02/2014
1		179 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/01/2014

Labeler - Wound Care USA, LLC (006745854)