NDC | 70645-804-26 |
Set ID | 6cf2e7af-9ede-4b47-a6b5-b88ecb8b423f |
Category | MEDICAL DEVICE |
Packager | 7T Pharma LLC |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | K020540 |
- SPL UNCLASSIFIED SECTION
-
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
-
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
- How is 7T LIDO GEL Supplied
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
7T LIDO
dressing, wound and burn, hydrogel w/drug and/or biologic gelProduct 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)