NULIDO- lidocaine hydrocloride 4% gel

NuLido by

Drug Labeling and Warnings

NuLido by is a Otc medication manufactured, distributed, or labeled by All Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingedients

• 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

• 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

Label Image

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

INGREDIENTS AND APPEARANCE

NULIDO 
lidocaine hydrocloride 4% gel

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53149-2100-4	120 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2017

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

Labeler - All Pharma LLC (078572520)

Establishment
Name	Address	ID/FEI	Business Operations
All Pharma LLC		078572520	MANUFACTURE(53149-2100)