SPL v6
SPL
SPL Set ID b28ebbb6-1112-4750-a2bb-f96b03fabe6e
Route
TOPICAL
Published
Effective Date 2022-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Water Cannabidiol Eucalyptus Oil Glycerin Lavender Oil Peppermint Oil Polyacrylic Acid (250000 Mw) Propylparaben Propylene Glycol Tartaric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-29

Description

Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4%

Uses

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, bruises.

Section 50565-1

Keep out of reach of children.If product is put in mouth, get medical help of contact a Poison Control Center right away. Package is not child resistant. Dispose of the used patches by folding sticky ends together.

Warnings

Do not useon the face or rashes, on wounds or damaged skin, in the eyes, mouth, or other mucous membranes, on genitals, with a heating pad, any patch from a pouch that has been opened for 7 or more days.

Ask a doctorbefore use if you are allergic to topical products, you are taking a diuretic, you have high blood pressure, heart disease, kidney disease, or you are pregnant.

When using this productwash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and consult your physician ifrash, irritation, or itching develops, or condition worsens.

If pregnant or breastfeeding, ask a doctor before use while breastfeeding and during the first 6 months of pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

For external use only

Directions

Adults and children 12 years and over: apply 1 to 2 patches to the affected area of intact skin. Lidocanna should be removed after 12 hours of continuous use and remain off for at least 12 hours.

Product Label

Active Ingredient

Lidocaine 4%

Other Information

Some individuals may not experience pain relief until several minutes or hours after applying the patch. Store in a cool, dry place. Protect the product from excessive moisture or sunlight. Store at 67-77°F (19-25°C).

Inactive Ingredients

Cannabidiol, eucalyptus oil, glycerin, glycol dihydroxy aluminum, lavender oil, peppermint oil, polyacrylic acid, propyl p-hydroxybenzoate, propylene glycol, tartaric acid, water


Structured Label Content

Uses

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, bruises.

Section 50565-1 (50565-1)

Keep out of reach of children.If product is put in mouth, get medical help of contact a Poison Control Center right away. Package is not child resistant. Dispose of the used patches by folding sticky ends together.

Purpose

Topical Anesthetic

Warnings

Do not useon the face or rashes, on wounds or damaged skin, in the eyes, mouth, or other mucous membranes, on genitals, with a heating pad, any patch from a pouch that has been opened for 7 or more days.

Ask a doctorbefore use if you are allergic to topical products, you are taking a diuretic, you have high blood pressure, heart disease, kidney disease, or you are pregnant.

When using this productwash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and consult your physician ifrash, irritation, or itching develops, or condition worsens.

If pregnant or breastfeeding, ask a doctor before use while breastfeeding and during the first 6 months of pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

For external use only

Directions

Adults and children 12 years and over: apply 1 to 2 patches to the affected area of intact skin. Lidocanna should be removed after 12 hours of continuous use and remain off for at least 12 hours.

Product Label

Active Ingredient

Lidocaine 4%

Other Information (Other information)

Some individuals may not experience pain relief until several minutes or hours after applying the patch. Store in a cool, dry place. Protect the product from excessive moisture or sunlight. Store at 67-77°F (19-25°C).

Inactive Ingredients (Inactive ingredients)

Cannabidiol, eucalyptus oil, glycerin, glycol dihydroxy aluminum, lavender oil, peppermint oil, polyacrylic acid, propyl p-hydroxybenzoate, propylene glycol, tartaric acid, water


Advanced Ingredient Data


Raw Label Data

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