NULIDO- lidocaine hydrocloride 4% gel 
All Pharma LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

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 2Ask 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

Label Image

Manufactured by:
All Pharma, LLC
Hialeah, FL 33016
www.allpharmallc.com
Made in the U.S.A.

NuLido Label

NULIDO 
lidocaine hydrocloride 4% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53149-2100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53149-2100-4120 mL in 1 TUBE; Type 0: Not a Combination Product10/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2017
Labeler - All Pharma LLC (117605075)
Establishment
NameAddressID/FEIBusiness Operations
All Pharma LLC117605075MANUFACTURE(53149-2100)

Revised: 10/2017
Document Id: 5b0d2255-bb8b-4b79-8c92-249bd776115c
Set id: 57904d54-494d-4859-8a8f-619e662d7fef
Version: 3
Effective Time: 20171018
 
All Pharma LLC