Lidocaine Plus Menthol

Lidocaine Plus Menthol
SPL v3
SPL
SPL Set ID 1d1ecb6f-9447-45d0-8a1f-d5e17efbf0f0
Route
TOPICAL
Published
Effective Date 2019-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g) Menthol (1 g)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Anhydrous Glycerin Kaolin Methylparaben Polyacrylic Acid (250000 Mw) Polysorbate 80 Propylene Glycol 1-(2-methylbutyrate) Propylparaben Povidone, Unspecified Sodium Polyacrylate (2500000 Mw) Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-01-14

Description

Lidocaine 4% Topical Anesthetic Menthol 1% Topical Anesthetic


Medication Information

Description

Lidocaine 4% Topical Anesthetic Menthol 1% Topical Anesthetic

Uses

Temporary relief of minor pain

Section 44425-7

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Section 50565-1
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 55105-1

Topical Anesthetic

Section 55106-9

Lidocaine 4% Topical Anesthetic

Menthol 1% Topical Anesthetic

Warnings
  • For External use only. Use only as directed.
Do Not Use

■ More than one patch on your body at a time

■ On cut, irritated or swollen skin

■ On puncture wounds

■ For more than one week without consulting a doctor

■ If you are allergic to any active or inactive ingredients

■ If pouch is damaged or opened.

Drug Facts

When Using:

■ Use only as directed

■ Read and follow all directions and warnings on this carton

■ Do not allow contact with the eyes

■ Do not use at the same time as other topical analgesics

■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use

■ Do not microwave

■ Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain

the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Distributed By:

Inactive Ingredients

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol,

propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

If Pregnant Or Breast Feeding
  • Ask a health professional before use.
Stop Use and Consult A Doctor If

■ Condition worsens

■ Redness is present

■ Irritation develops

■ Symptoms persist for more than 7 days or clear up and occur again within a few days

■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

Directions Adults and Children 12 Years of Age and Over:

Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side

of patch to affected area. Use one patch for up to 12 hours. Discard after single use.

Children under 12 years of age: consult a physician.


Structured Label Content

Uses (USES)

Temporary relief of minor pain

Section 44425-7 (44425-7)

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

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 55105-1 (55105-1)

Topical Anesthetic

Section 55106-9 (55106-9)

Lidocaine 4% Topical Anesthetic

Menthol 1% Topical Anesthetic

Warnings (WARNINGS)
  • For External use only. Use only as directed.
Do Not Use (DO NOT USE)

■ More than one patch on your body at a time

■ On cut, irritated or swollen skin

■ On puncture wounds

■ For more than one week without consulting a doctor

■ If you are allergic to any active or inactive ingredients

■ If pouch is damaged or opened.

Drug Facts

When Using: (WHEN USING:)

■ Use only as directed

■ Read and follow all directions and warnings on this carton

■ Do not allow contact with the eyes

■ Do not use at the same time as other topical analgesics

■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use

■ Do not microwave

■ Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain

the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Distributed By:

Inactive Ingredients (INACTIVE INGREDIENTS)

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol,

propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

If Pregnant Or Breast Feeding (If pregnant or breast feeding)
  • Ask a health professional before use.
Stop Use and Consult A Doctor If (Stop use and consult a doctor if)

■ Condition worsens

■ Redness is present

■ Irritation develops

■ Symptoms persist for more than 7 days or clear up and occur again within a few days

■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

Directions Adults and Children 12 Years of Age and Over: (DIRECTIONS Adults and children 12 years of age and over:)

Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side

of patch to affected area. Use one patch for up to 12 hours. Discard after single use.

Children under 12 years of age: consult a physician.


Advanced Ingredient Data


Raw Label Data

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