7T LIDO- lidocaine hydrochloride and benzethonium chloride gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)

Available from:

7T Pharma LLC

Administration route:

TOPICAL

Therapeutic indications:

7T LIDO GEL is intended to be used under the supervision of a healthcare professional to be used as local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.

Authorization status:

Premarket Notification

Summary of Product characteristics

7T LIDO- DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC GEL
7T PHARMA LLC
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7T LIDO GEL
7T PHARMA, LLC
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7T LIDO GEL
RX ONLY
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
7T LIDO GEL DESCRIPTION
7T LIDO GEL is a soothing viscous hydrogel wound dressing containing
lidocaine 2% as a topical
anesthetic intended for use in the local management of painful skin
wounds. 7T LIDO GEL also helps
to relieve dry, waxy skin by maintaining a moist wound and skin
environment, which is beneficial to the
healing process.
7T LIDO GEL contains: Lidocaine HCl, Benzethonium Chloride, Aloe
Barbadensis Leaf (Aloe Vera
Gel) Juice, Aqua (Deionized Water), Glycerin, Hydrolyzed Collagen,
Hydroxyethylcellulose, Sodium
Alginate, Tocopheryl Acetate (Vitamin E), Triethanolamine.
INDICATIONS AND USES
7T LIDO GEL is intended to be used under the supervision of a
healthcare professional to be used as
local management of skin wounds, including pressure ulcers, venous
stasis ulcers, first and second
degree burns, and superficial wounds and scrapes.
WARNINGS
For external use only. Do not use this product if you are allergic to
any of the ingredients listed. Avoid
contact with eyes. Sterile unless opened or damaged. If this product
is applied properly and skin
irritation still occurs, discontinue use and consult your physician.
If ingested, get medical help or
contact Poison Control Center right away.
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
This medication should be used as directed by your physician during
pregnancy or while breastfeeding.
Consult your doctor about the risks and benefits.
CAUTION: Federal law restricts this device to sale by or on the order
of a physician
ADVERSE REACTIONS
On rare occasions, the gel may cause temporary redness, stinging,
burning or irritation and normally
disappear when the medication is discontinued.
HOW IS 7T LIDO GEL SUPPLIED
7T LIDO GEL is supplied as a gel in:
3 oz. (85g) tube
NDC: 70645-804-26
STORE AT 20°-25°C (68° TO 77°F); KEEP AWAY FROM HEAT AND