Healthwise Lidocaine + Menthol Pain Relief Patch

Healthwise Lidocaine + Menthol Pain Relief Patch
SPL v2
SPL
SPL Set ID ce2e9d9b-b4a4-ab61-e053-2a95a90a0642
Route
TOPICAL
Published
Effective Date 2021-10-01
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 Kaolin Glycerin Methylparaben Polyacrylic Acid (250000 Mw) Polysorbate 80 Propylene Glycol Propylparaben Sodium Polyacrylate (2500000 Mw) Tartaric Acid Titanium Dioxide Water Povidone, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-01

Description

Lidocaine 4% Menthol 1%

Purpose

Topical anesthetic Topical analgesic


Medication Information

Purpose

Topical anesthetic

Topical analgesic

Description

Lidocaine 4% Menthol 1%

Use

for the temporary relief minor pain

Active I

Lidocaine 4%

Menthol 1%

Keep Out

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.

Warnings

For external use only

Directions

adults and children 12 years of age and older:

■ clean and dry affected area

■ Carefully remove backing from patch starting at a corner

■ Apply sticky side of patch to affected area

■ use 1 patch for up to 12 hours

■ Discard patch after single use

children under 12 years of age: consult a physician

Do Not Use

■ more than 1 patch on your body at a time

■ on a 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

Inactive Ingredients

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Principal Display Panel

When Using This Product

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.

Stop Use and Ask 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 pain, swelling, or blistering where the product was applied

If Pregnant Or Breast Feeding,

ask a health professional before use.


Structured Label Content

Use

for the temporary relief minor pain

Purpose

Topical anesthetic

Topical analgesic

Active I (Active i)

Lidocaine 4%

Menthol 1%

Keep Out (Keep out)

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.

Warnings

For external use only

Directions

adults and children 12 years of age and older:

■ clean and dry affected area

■ Carefully remove backing from patch starting at a corner

■ Apply sticky side of patch to affected area

■ use 1 patch for up to 12 hours

■ Discard patch after single use

children under 12 years of age: consult a physician

Do Not Use (Do not use)

■ more than 1 patch on your body at a time

■ on a 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

Inactive Ingredients (Inactive ingredients)

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)

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.

Stop Use and Ask A Doctor If (Stop use and ask 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 pain, swelling, or blistering where the product was applied

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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