LIDOTREX- dressing, wound and burn, hydrogel w/drug and/or biologic    
Sterling-Knight Pharmaceuticals, LLC

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Lidotrex Gel
Prescription Only | Rx Only

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

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

Rev 012518-1

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label

LIDOTREX 
dressing, wound and burn, hydrogel w/drug and/or biologic
Product Information
Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:69336-835
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:69336-835-3028.33 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK02054001/01/2017
Labeler - Sterling-Knight Pharmaceuticals, LLC (079556942)

Revised: 3/2018
Document Id: 2915988b-e964-493c-83d2-fe8c6e9642af
Set id: 40e2cbc8-3703-4371-bfda-8a7be74643e0
Version: 2
Effective Time: 20180320
 
Sterling-Knight Pharmaceuticals, LLC