TETRAVEX- tetracaine hydrochloride  
Sterling-Knight Pharmaceuticals, LLC

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Tetravex Gel
Prescription Only | Rx Only

Tetravex 2%
Tetracaine Gel
Prescription Only | Rx Only

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

Ingredients: Water, 2% Tetracaine, Collagen, Aloe Vera gel, Sodium alginate, Glycerin, Hydroxyethylcellulose, Triethanolamine, Benzethonium chloride.

DIRECTIONS:

Cleanse wound then apply Tetravex 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.

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.

PRECAUTIONS:

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].

Tetravex wound gel is supplied as a gel in: 1 oz. (28.33g) tube.

NDC 69336-823-30
Distributed By: Sterling-Knight Pharmaceuticals, LLC Ripley, MS 38663
Rev 052218-1

LABEL:

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

tetra

TETRAVEX 
dressing, wound and burn, interactive
Product Information
Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:69336-823
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV) TETRACAINE HYDROCHLORIDE20 mg  in 1000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C)  
aloe vera leaf (UNII: ZY81Z83H0X)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:69336-823-3028.33 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK02054006/06/201810/24/2018
Labeler - Sterling-Knight Pharmaceuticals, LLC (079556942)

Revised: 10/2018
 
Sterling-Knight Pharmaceuticals, LLC