SPL v4
SPL
SPL Set ID 9254dada-4e32-43a0-892b-c488d68e23e7
Route
TOPICAL
Published
Effective Date 2022-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (170 mg)
Inactive Ingredients
Aloe Vera Leaf Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Hydrolyzed Elastin, Bovine, Alkaline (1000 Mw) Glycerin Hyaluronic Acid Trolamine Phenoxyethanol Methylparaben Ethylparaben Propylparaben Butylparaben Isobutylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-05-24

Description

Active Ingredients Benzalkonium Chloride (0.1%)

Purpose

Purpose Antimicrobial


Medication Information

Purpose

Purpose

Antimicrobial

Description

Active Ingredients Benzalkonium Chloride (0.1%)

Uses

Uses



    * 1st and 2nd Degree Burns

    * Stasis Ulcers

    * Pressure Ulcers

    * Diabetic Ulcers

    * Lacerations

    * Abrasions

    * Skin Tears

    * Surgical Incision Sites

    * Device Insertion Sites

    * Graft Sites

    * Donor Sites

Warnings

Warnings



For external use only.

Directions

Directions

Evenly apply RevitaDERM Wound Care approximately 1/8 inch to 1/4 inch thick to the wound area. Cover wound with appropriate dressing. Repeat as necessary to keep the wound moist.

Product Label

Blaine Labs



RevitaDERM WOUND CARE GEL



3 fl. oz. PHYSICIAN FORMULA



NDC: 63347-120-01



(800) 307-8818   [email protected]    www.BlaineLabs.com    Blaine Labs, Inc.  Santa Fe Springs, CA 90670   Rev. 20120820

res

Active Ingredients

Active Ingredients

Benzalkonium Chloride (0.1%)

Inactive Ingredients

Inactive ingredients

Aloe Barbadensis (Aloe) Leaf Juice, Aloe Barbadensis (Aloe) oil extract, Carbomer, Collagen, Elastin, Glycerin, Hyaluronic Acid, Triethanolamine, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylparaben.

Ask A Doctor Before Use

Ask a doctor before use



RevitaDERM Wound Care Gel is for external use only. Avoid contact with eyes. If you get it in your eyes, rinse immediately with cool tap water. RevitaDERM Wound Care Gel may become discolored when it mixes with fluid from the wound. This is normal and not a cause for concern. Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor. Talk with your doctor before you use any other medicines or cleansers on your skin. RevitaDERM Wound Care Gel does not contain sunscreen. Ask you doctor before you use RevitaDERM Wound Care Gel if you must be outside for a long period of time. If your symptoms do not get better or if they get worse, check with your doctor.

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.


Structured Label Content

Uses

Uses



    * 1st and 2nd Degree Burns

    * Stasis Ulcers

    * Pressure Ulcers

    * Diabetic Ulcers

    * Lacerations

    * Abrasions

    * Skin Tears

    * Surgical Incision Sites

    * Device Insertion Sites

    * Graft Sites

    * Donor Sites

Purpose

Purpose

Antimicrobial

Warnings

Warnings



For external use only.

Directions

Directions

Evenly apply RevitaDERM Wound Care approximately 1/8 inch to 1/4 inch thick to the wound area. Cover wound with appropriate dressing. Repeat as necessary to keep the wound moist.

Product Label

Blaine Labs



RevitaDERM WOUND CARE GEL



3 fl. oz. PHYSICIAN FORMULA



NDC: 63347-120-01



(800) 307-8818   [email protected]    www.BlaineLabs.com    Blaine Labs, Inc.  Santa Fe Springs, CA 90670   Rev. 20120820

res

Active Ingredients

Active Ingredients

Benzalkonium Chloride (0.1%)

Inactive Ingredients

Inactive ingredients

Aloe Barbadensis (Aloe) Leaf Juice, Aloe Barbadensis (Aloe) oil extract, Carbomer, Collagen, Elastin, Glycerin, Hyaluronic Acid, Triethanolamine, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylparaben.

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

Ask a doctor before use



RevitaDERM Wound Care Gel is for external use only. Avoid contact with eyes. If you get it in your eyes, rinse immediately with cool tap water. RevitaDERM Wound Care Gel may become discolored when it mixes with fluid from the wound. This is normal and not a cause for concern. Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor. Talk with your doctor before you use any other medicines or cleansers on your skin. RevitaDERM Wound Care Gel does not contain sunscreen. Ask you doctor before you use RevitaDERM Wound Care Gel if you must be outside for a long period of time. If your symptoms do not get better or if they get worse, check with your doctor.

Keep Out of Reach of Children (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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)