Lidotrex by Sterling-Knight Pharmaceuticals, LLC LIDOTREX-

Lidotrex by

Drug Labeling and Warnings

Lidotrex by is a Other medication manufactured, distributed, or labeled by Sterling-Knight Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Lidotrex is a soothing wound gel that promotes a moist wound environment that is ideal for the healing process.

Directions:

Cleanse wound then apply Lidotrex to the wound and skin surrounding the wound 3 - 4 times daily.

Indications:

For the local management of painful skin wounds, including:
Pressure ulcers
Venus stasis ulcers
Superficial wounds and scrapes
1st and 2nd degree burns

Warnings:

External use only. Do not use this product if you are allergic to any of the ingredients. Avoid contact with eyes. Sterile unless opened or damaged.

Caution:

Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.

Storage:

Store at 25°C (77°F): excursions permitted to 15°-30°C (59°-86°F). Protect from freezing [See USP Controlled Room Temperature].

Ingredients:

Water, Lidocaine HCl, Collagen, Aloe Vera gel, Sodium alginate, Glycerin, Hydroxyethylcellulose, Triethanolamine, Benzethonium chloride.

CALL YOUR DOCTOR ABOUT SIDE EFFECTS:

Call your doctor about side effects. You may report side effects to Sterling Knight Pharmaceuticals, LLC at 1-888-460-1531 or the FDA at 1-800-FDA-1088.

How Supplied:

Lidotrex wound gel is supplied as a gel in:
1 oz. (28.33g) tube, NDC: 69336-835-30

SPL UNCLASSIFIED SECTION

Distributed By:
Sterling-Knight Pharmaceuticals, LLC
Ripley, MS 38663

Rev 012518-1

Principal Display Panel

INGREDIENTS AND APPEARANCE

LIDOTREX 
dressing, wound and burn, hydrogel w/drug and/or biologic

Product Information
Product Type	PRESCRIPTION MEDICAL DEVICE	Item Code (Source)	NHRIC:69336-835

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A)
BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
TROLAMINE (UNII: 9O3K93S3TK)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)

Product Characteristics
(SPLSTERILEUSE)	false
(SPLMRISAFE)	true

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:69336-835-30	28.33 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
premarket notification	K020540	01/01/2017

Labeler - Sterling-Knight Pharmaceuticals, LLC (079556942)