40b452a3-76b7-2433-e063-6294a90ab6b4

SPL v1
SPL
SPL Set ID 40b452a3-76b7-2433-e063-6294a90ab6b4
Route
topical
Published
Effective Date 2025-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (5 g)
Inactive Ingredients
water arnica montana flower benzyl alcohol propylene glycol emu oil lecithin, soybean carbomer 934 .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-10-09

Purpose

For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders

Description

LIDOCAINE 5%


Medication Information

Warnings

For external use only

Uses

Directions

Adults: 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.Children under 12 years of age: Consult a doctor.

Apply externally to the affected area up to 6 times daily.

Purpose

For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders

Inactive Ingredients

Water: 82%

Arnica: 2%

Emu oil: 2%

Lecithin (Soybean): 2%

Propylene Glycol: 2%

Tocopheryl Acetate: 2%

Carbomer 934: 2%

Benzyl Alcohol: 1%

Description

LIDOCAINE 5%

Principal Display Panel

Stop Use

Stop using and ask a doctor if:

Condition worsens or does not improve within 7 days.

An allergic reaction occurs to ingredients in this product.

The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Symptoms clear up and return within a few days.

Keep out of reach of children.

If swallowed, get medical help.

If pregnant or breastfeeding, ask a health professional before use.

Do Not Use

on damaged or broken skin.

When Using

When using this product:

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 Ingredients

LIDOCAINE 5%

Dosage & Administration

Adults and children 12 years and older: Apply externally to the affected area. APPLY UP TO 6 TIMES DAILY.

Children under 12 years of age: Consult a doctor.

Keep Out of Reach of Children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Warnings

For external use only

Uses

Directions

Adults: 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.Children under 12 years of age: Consult a doctor.

Apply externally to the affected area up to 6 times daily.

Purpose

For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders

Inactive Ingredients (Inactive ingredients)

Water: 82%

Arnica: 2%

Emu oil: 2%

Lecithin (Soybean): 2%

Propylene Glycol: 2%

Tocopheryl Acetate: 2%

Carbomer 934: 2%

Benzyl Alcohol: 1%

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Stop Use

Stop using and ask a doctor if:

Condition worsens or does not improve within 7 days.

An allergic reaction occurs to ingredients in this product.

The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Symptoms clear up and return within a few days.

Keep out of reach of children.

If swallowed, get medical help.

If pregnant or breastfeeding, ask a health professional before use.

Do Not Use

on damaged or broken skin.

When Using

When using this product:

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 Ingredients

LIDOCAINE 5%

Dosage & Administration (Dosage & administration)

Adults and children 12 years and older: Apply externally to the affected area. APPLY UP TO 6 TIMES DAILY.

Children under 12 years of age: Consult a doctor.

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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