LIDONEX- lidocaine hcl, menthol liquid

Lidonex by

Drug Labeling and Warnings

Lidonex by is a Otc medication manufactured, distributed, or labeled by Aldama Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Lidocaine HCL, USP 4%

Menthol USP 5%

PURPOSE

Purpose

Topical Anesthetic

Pain Relieving

INDICATIONS & USAGE

Use

For temporarily relief of pain

WARNINGS

Warnings

For external use only

Flammable: Keep away from fire or flame

Do not use

• on wounds or damaged skin
• in large quantaties
• with a heating pad
• if you are allergic to any ingredients of this product

When using this product

• use only as directed.
• avoid contact with the eyes, mucous membranes or rashes
• do not bandage tightly

Stop use and ask doctor if

• skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
• condition worsens
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding.Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Adults and children over 12 years of age and over

• clean and dry affected area
• apply to affected area not more than 3 to 4 times daily

Children under 12 years of age:Consult a doctor

INACTIVE INGREDIENT

Inactive ingredients

glycerin, isopropyl alcohol, methylparaben, propylparaben, purified water, xanthan gum

STORAGE AND HANDLING

• avoid storing prouct in direct sunlight
• prodect product from excessive moisture
• store with lid closed tightly

QUESTIONS

Questions or comments?(305) 592 - 9216 or info@aldamapharm.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDONEX 
lidocaine hcl, menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73564-804
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73564-804-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/01/2025

Labeler - Aldama Pharmaceuticals, Inc (119484030)

Establishment
Name	Address	ID/FEI	Business Operations
Aldama Pharmaceuticals, Inc		119484030	manufacture(73564-804)