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NDC 76420-0140-12 NuLido 4; 1 mg/mL; mg/mL Details

NuLido 4; 1 mg/mL; mg/mL

NuLido is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Asclemed USA, Inc.. The primary component is LIDOCAINE; MENTHOL.

Product Information

NDC	76420-0140
Product ID	76420-140_b36a1892-7185-cf6a-e053-2995a90a9b9a
Associated GPIs	90859902884040
GCN Sequence Number	077805
GCN Sequence Number Description	lidocaine HCl/menthol GEL (ML) 4 %-1 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	43952
HICL Sequence Number	036762
HICL Sequence Number Description	LIDOCAINE HCL/MENTHOL
Brand/Generic	Generic
Proprietary Name	NuLido
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine Hydrocloride 4%
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	4; 1
Active Ingredient Units	mg/mL; mg/mL
Substance Name	LIDOCAINE; MENTHOL
Labeler Name	Asclemed USA, Inc.
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 76420-0140-12 (76420014012)

Pricing Information	N/A
NDC Package Code	76420-140-12
Billing NDC	76420014012
Package	120 mL in 1 TUBE (76420-140-12)
Marketing Start Date	2020-11-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1d16d521-1787-4be2-b3e8-e25d30c08d34 Details

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

SPL UNCLASSIFIED SECTION

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/01/2017

Labeler - Asclemed USA, Inc. (059888437)

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

Revised: 11/2020

Document Id: b36a1892-7185-cf6a-e053-2995a90a9b9a

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

Version: 1

Effective Time: 20201106