85150-004

85150-004
SPL v1
SPL
SPL Set ID 2e899851-b3cd-0758-e063-6294a90afea8
Route
TOPICAL
Published
Effective Date 2025-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Propylene Glycol Horse Chestnut Soybean Emu Oil Menthol Arnica Montana Flower Curcuma Longa (turmeric) Root Powder Aqua Alpha-tocopherol Acetate Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-20

Description

Lidocaine 5%

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Lidocaine 5%

Use

For the temporary relief of localized pain, itching, or discomfort from minor skin irritations.

Stop Use

If condition worsens or does not improve within 7 days. If allergic reaction occurs to ingredients in this product. If symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. If symptoms clear up and return within a few days.

Warnings

For external use only.

Ask Doctor

If pregnant or breastfeeding. If condition worsens or does not improve within 7 days. If allergic reaction occurs to ingredients in this product. If symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. If symptoms clear up and return within a few days.

Directions

When practical, clean the area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 4 times a day. Children under 12 years: consult a doctor. To use finger cots: roll one finger cot over the finger. Gently squeeze cream on to the finger cot. Smooth a layer of the cream.

Do Not Use

If allergic to any ingredients.

When Using

Do not get into the eyes. Do not exceed recommended dosage unless directed by a doctor. Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Active Ingredient

Lidocaine 5%

Other Information

Store at room temperature 59° - 86°F (15° - 30°C). Avoid direct sunlight. Do not use if tamper - evident packaging has been breached or is missing.

Inactive Ingredients

Tocopheryl Acetate, Emu Oil, Propylene Glycol, Arnica, Glycerin, Menthol, Aescinns Hippocastanum (Horse Chestnut) Extract, Lecithin(Soybean), Curcuma Longa Extract, Aqua

Principal Display Panel

Keep Oot of Reach of Children

Keep out of reach of children. If swallowed, get medical help.


Structured Label Content

Use

For the temporary relief of localized pain, itching, or discomfort from minor skin irritations.

Purpose

Local Anesthetic

Stop Use

If condition worsens or does not improve within 7 days. If allergic reaction occurs to ingredients in this product. If symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. If symptoms clear up and return within a few days.

Warnings

For external use only.

Ask Doctor

If pregnant or breastfeeding. If condition worsens or does not improve within 7 days. If allergic reaction occurs to ingredients in this product. If symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. If symptoms clear up and return within a few days.

Directions

When practical, clean the area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 4 times a day. Children under 12 years: consult a doctor. To use finger cots: roll one finger cot over the finger. Gently squeeze cream on to the finger cot. Smooth a layer of the cream.

Do Not Use (Do not use)

If allergic to any ingredients.

When Using

Do not get into the eyes. Do not exceed recommended dosage unless directed by a doctor. Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Active Ingredient

Lidocaine 5%

Other Information (Other information)

Store at room temperature 59° - 86°F (15° - 30°C). Avoid direct sunlight. Do not use if tamper - evident packaging has been breached or is missing.

Inactive Ingredients (Inactive ingredients)

Tocopheryl Acetate, Emu Oil, Propylene Glycol, Arnica, Glycerin, Menthol, Aescinns Hippocastanum (Horse Chestnut) Extract, Lecithin(Soybean), Curcuma Longa Extract, Aqua

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

Keep out of reach of children. If swallowed, get medical help.


Advanced Ingredient Data


Raw Label Data

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