REVITADERM WOUND CARE- benzalkonium chloride gel

RevitaDERM Wound Care by

Drug Labeling and Warnings

RevitaDERM Wound Care by is a Otc medication manufactured, distributed, or labeled by Blaine Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active Ingredients

Benzalkonium Chloride (0.1%)

Purpose

Purpose

Antimicrobial

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.

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.

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.

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.

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.

Product Label

Blaine Labs

RevitaDERM WOUND CARE GEL

3 fl. oz. PHYSICIAN FORMULA

NDC: 63347-120-01

(800) 307-8818   Info@BlaineLabs.com    www.BlaineLabs.com    Blaine Labs, Inc.  Santa Fe Springs, CA 90670   Rev. 20120820

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INGREDIENTS AND APPEARANCE

REVITADERM WOUND CARE  
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63347-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	170 mg  in 89 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) (UNII: ZR28QKN0WT)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONIC ACID (UNII: S270N0TRQY)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63347-120-01	89 mL in 1 TUBE; Type 0: Not a Combination Product	05/24/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/24/2012

Labeler - Blaine Labs Inc. (017314571)

Registrant - Blaine Labs Inc. (017314571)

Establishment
Name	Address	ID/FEI	Business Operations
Blaine Labs Inc.		017314571	manufacture(63347-120)