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

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7T Lido Gel

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

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

Principal Display Panel

Principal Display Panel

7T LIDO 
dressing, wound and burn, hydrogel w/drug and/or biologic gel
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:70645-804
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 mg  in 100 mg
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.5 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
COLLAGEN, SOLUBLE, FISH SKIN (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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:70645-804-2685000 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Premarket NotificationK02054008/01/201803/01/2024
Labeler - 7T Pharma LLC (080220022)

Revised: 3/2024
 
7T Pharma LLC