NuLido by Asclemed USA, Inc. / ASCLEMED USA INC. DBA ENOVACHEM NuLido

Drug Details [pdf]

NULIDO- lidocaine hydrocloride 4% gel
Asclemed USA, Inc.

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NuLido

Active Ingedients

Each milliliter contains
Active Ingredient	Purpose
Lidocaine Hydrochloride 4.0%	Topical Anesthetic
Menthol 1.0%	Topical Anesthetic

INACTIVE INGREDIENT

Carbomer copolymer type b, Isopropyl Alcohol, water, trolamine

Warnings

For external use only.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away. Package not child resistant.

When using this product

■ avoid contact with eyes, genitals, and other mucous membranes. If eye contact occurs, rinse thoroughly with water.
■ do not use on open wounds, cuts, damaged or infected skin
■ do not use With a bandage or a heating pad

Ask your doctor before use if

■ you are allergic to any ingredients
■ you are pregnant or breast-feeding

Uses

Temporarily relieves minor aches and muscle pains associated with:

■ arthritis

■ simple back pain

■ strains

■ muscle soreness

Purpose

Temporarily relieves minor aches and muscle pains associated with:

■ arthritis
■ simple back pain
■ strains
■ muscle soreness

Dosage & Administration

Apply to the affected area.
Adults and children 12 years and older	Apply to the affected area. Product may be used as necessary, but should not be used more than four times per day. Wash hands immediately afterwards.
Children under 2	Ask a doctor

Other Information

■ avoid storing product in direct sunlight
■ protect product from excessive moisture
■ store at 67-77°F (19-25°C)

Stop Use and Ask Doctor

■ if condition worsens or symptoms persist for more than 7 days
■ if excessive skin irritation occurs

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

PRINCIPAL DISPLAY PANEL

NuLido Label

NULIDO
lidocaine hydrocloride 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76420-140(NDC: 53149-2100)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 mg in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 76420-140-12	120 mL in 1 TUBE; Type 0: Not a Combination Product	11/06/2020	10/05/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	10/01/2017	10/05/2023

Labeler - Asclemed USA, Inc. (059888437)

Name	Address	ID/FEI	Business Operations
Establishment
ASCLEMED USA INC. DBA ENOVACHEM		059888437	relabel(76420-140)

Revised: 10/2023

Document Id: 07065d2b-476f-c2aa-e063-6394a90aadd1

Set id: 1d16d521-1787-4be2-b3e8-e25d30c08d34

Version: 2

Effective Time: 20231006