Dermawound Professional Care Wound Care Topical Ointment Venous Stasis Formula ®

Dermawound Professional Care Wound Care Topical Ointment Venous Stasis Formula ®
SPL v5
SPL
SPL Set ID 6221ba86-8b7f-48c8-8284-6950f9fc36b1
Route
TOPICAL
Published
Effective Date 2014-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (1.27 g)
Inactive Ingredients
Sucrose Calcium Carbonate Glycerin Xanthan Gum Methylparaben Water Povidone-iodine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-02-01

Description

Benzocaine Hydrochloride (1.27%)

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Benzocaine Hydrochloride (1.27%)

Uses

topical pain relief of minor

  • cuts
  • scrapes
  • burns
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.
Warnings

For external use only

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.
Do Not Use
  • in the eyes
  • if you have methemoglobinemia
  • if pregnant or lactating
Active Ingredient

Benzocaine Hydrochloride (1.27%)

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

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.

Package/label Principal Display Panel

DermaWound Professional Care ®

Wound Care Local Anesthetic Ointment

Venous Stasis Formula

Net Wt. 6 oz. (179 g)

Carton Label




Structured Label Content

Uses

topical pain relief of minor

  • cuts
  • scrapes
  • burns
Purpose

Local Anesthetic

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.
Warnings

For external use only

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.
Do Not Use (Do not use)
  • in the eyes
  • if you have methemoglobinemia
  • if pregnant or lactating
Active Ingredient (Active ingredient)

Benzocaine Hydrochloride (1.27%)

Other Information
  • Store at 59°-86°F (15-30°C)
  • Avoid Heat and Direct Sunlight
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (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

Ask A Doctor Before Use (Ask a doctor before use)

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

Stop Use and Ask A Doctor If (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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

DermaWound Professional Care ®

Wound Care Local Anesthetic Ointment

Venous Stasis Formula

Net Wt. 6 oz. (179 g)

Carton Label




Advanced Ingredient Data


Raw Label Data

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