7T LIDO- lidocaine hydrochloride and benzethonium chloride gel

7T Lido by

Drug Labeling and Warnings

7T Lido by is a Other medication manufactured, distributed, or labeled by 7T Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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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 protect from freezing. [See USP Controlled Room Temperature.]

SPL UNCLASSIFIED SECTION

Manufactured for:
7T Pharma, LLC
Los Angeles, CA 90064

PRINCIPAL DISPLAY PANEL

7T Lido Gel

Rx ONLY

NDC: 70645-804-26

3oz (85g)

INGREDIENTS AND APPEARANCE

7T LIDO 
dressing, wound and burn, hydrogel w/drug and/or biologic gel

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:70645-804
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2 mg  in 100 mg
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.5 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:70645-804-26	85000 mg 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	08/01/2018

Labeler - 7T Pharma LLC (080220022)