EUDERMIS RX- benzalkonium chloride gel

EUDERMIS Rx by

Drug Labeling and Warnings

EUDERMIS Rx by is a Prescription medication manufactured, distributed, or labeled by Blaine Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT ................................. PURPOSE

BENZALKONIUM CHLORIDE 0.1% ........... ANTIMICROBIAL

INDICATIONS & USAGE

INDICATIONS

• FOR MANAGEMET OF STAGE 1-IV PRESSURE ULCERS, STASIS ULCERS,

DIABETIC SKIN ULCERS, POST-SURGICAL INCISIONS, FIRST AND

SECOND-DEGREE BURNS, CUTS, ABRASIONS AND SKIN IRRITATIONS.

SPL UNCLASSIFIED SECTION

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES; RINSE

IMMEDIATELY WITH COOL TAP WATER IF CONTACT OCCURS.

DO NOT USE MORE THATN THE RECOMMENDED DOSE OR LONGER

THAN PRESCRIBED WITHOUT CHECKING WITH YOUR PHYSICIAN.

TALK WITH YOUR PHYSICIAN BEFORE YOU USE ANY OTHER MEDICINES

OR CLEANSERS ON YOUR SKIN. ASK YOUR PHYSICIAN BEFORE

PROLONGED SUN EXPOSURE. IF YOUR SYMPTOMS DO NOT

IMPROVE OR IF THEY WORSEN, CONTACT YOUR PHYSICIAN.

OTHER SAFETY INFORMATION

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON

CONTROL CENTER IMMEDIATELY.

DOSAGE & ADMINISTRATION

DIRECTIONS

CLEAN THE WOUND BEFORE EACH APPLICATION. APPLY A THIN

LAYER OF EUDERMIS® WOUND CARE GEL TO THE WOUND

SURFACE AND SKIN IMMEDIATELY SURROUNDING THE WOUND.

COVER THE WOUND AS DIRECTED BY YOUR PHYSICIAN.

OTHER SAFETY INFORMATION

CONTAINS EGGSHELL MEMBRANE POWDER - A NON-ALLERGENIC

ORGANIC SOURCE OF SOLUBILIZED PROTEIN TISSUE GROWTH

FACTORS INCLUDING COLLAGEN, ELASTIN, HYALURONIC ACID,

EIGHT ESSENTIAL AMINO ACIDS AND TRANSFORMING

GROWTH FACTOR - b.

Product Package

BY PRESRIPTION ONLY

BLAINE LABS®

EUDERMIS®
WOUND CARE GEL

BENZALKONIUM CHLORIDE
IN A GEL CONTAINING
TRANSFORMING GROWTH FACTOR - ß

3.0 FL OZ (88.7 mL)

MANUFACTURED BY:                                 QUESTIONS OR COMMENTS?
BLAINE LABS, INC.                                    CALL 800.307.8818
11037 LOCKPORT PLACE M-F,                 8AM-5PM (PST)
SANTA FE SPRINGS, CA 90670

REV20190215                                                                  80000-01-TB01

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INGREDIENTS AND APPEARANCE

EUDERMIS RX 
benzalkonium chloride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 63347-900
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0887 g  in 88.7 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
EGG SHELL MEMBRANE (UNII: N7QBR4212V)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
HYALURONIC ACID (UNII: S270N0TRQY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
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: 63347-900-01	88.7 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/01/2019

Labeler - Blaine Labs Inc. (017314571)

Registrant - Blaine Labs Inc. (017314571)

Establishment
Name	Address	ID/FEI	Business Operations
Blaine Labs Inc.		017314571	manufacture(63347-900)