Acolye Numbing Cream Anorectal(hemorrhoidal) Cream

Acolye Numbing Cream Anorectal(hemorrhoidal) Cream
SPL v1
SPL
SPL Set ID 40b0e8d6-4686-960b-e063-6294a90a016e
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
Arnica Montana Flower Emu Oil Benzyl Alcohol Water .alpha.-tocopherol Acetate Carbomer 934 Propylene Glycol Lecithin, Soybean

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-09

Description

LIDOCAINE 5%

Purpose

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


Medication Information

Purpose

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

Description

LIDOCAINE 5%

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.

Stop Use

Stop and consult a doctor if

An allergic reaction is observed.

Symptoms such as redness, irritation, swelling, pain, or others begin or worsen.

Does not show improvement within 7 days.

Warnings

For external use only

Do Not Use

on damaged or broken skin.

When Using

When using this product

Use only as much as recommended, unless a doctor advises otherwise.

Do not insert into the rectum with fingers or any mechanical device or applicator.

Active Ingredients

LIDOCAINE 5%

Inactive Ingredients

Water: 82%

Arnica: 2%

Emu oil: 2%

Lecithin (Soybean): 2%

Propylene Glycol: 2%

Tocopheryl Acetate: 2%

Carbomer 934: 2%

Benzyl Alcohol: 1%

Dosage & Administration

Squeeze out an appropriate amount of Numbing Cream and spread evenly on skin.

Principal Display Panel

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

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

Stop Use

Stop and consult a doctor if

An allergic reaction is observed.

Symptoms such as redness, irritation, swelling, pain, or others begin or worsen.

Does not show improvement within 7 days.

Warnings

For external use only

Do Not Use

on damaged or broken skin.

When Using

When using this product

Use only as much as recommended, unless a doctor advises otherwise.

Do not insert into the rectum with fingers or any mechanical device or applicator.

Active Ingredients

LIDOCAINE 5%

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%

Dosage & Administration (Dosage & administration)

Squeeze out an appropriate amount of Numbing Cream and spread evenly on skin.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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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