Lidonex Roll-on Liquid

Lidonex Roll-on Liquid
SPL v2
SPL
SPL Set ID 365cf19c-70e0-c4e9-e063-6294a90ac428
Route
TOPICAL
Published
Effective Date 2025-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Glycerin Isopropyl Alcohol Methylparaben Propylparaben Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

Active Ingredient Lidocaine HCL, USP 4% Menthol USP 5%


Medication Information

Warnings and Precautions

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
Indications and Usage

Use

For temporarily relief of pain

Dosage and 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

Description

Active Ingredient Lidocaine HCL, USP 4% Menthol USP 5%

Section 44425-7
  • avoid storing prouct in direct sunlight
  • prodect product from excessive moisture
  • store with lid closed tightly
Section 50565-1

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

Section 51727-6

Inactive ingredients

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

Section 51945-4

Section 53413-1

Questions or comments?(305) 592 - 9216 or [email protected]

Section 53414-9

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

Section 55105-1

Purpose

Topical Anesthetic

Pain Relieving

Section 55106-9

Active Ingredient

Lidocaine HCL, USP 4%

Menthol USP 5%


Structured Label Content

Indications and Usage (34067-9)

Use

For temporarily relief of pain

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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
Section 44425-7 (44425-7)
  • avoid storing prouct in direct sunlight
  • prodect product from excessive moisture
  • store with lid closed tightly
Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?(305) 592 - 9216 or [email protected]

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Topical Anesthetic

Pain Relieving

Section 55106-9 (55106-9)

Active Ingredient

Lidocaine HCL, USP 4%

Menthol USP 5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)