82929-011

82929-011
SPL v1
SPL
SPL Set ID 49fcbe81-34b6-5906-e063-6294a90aa65b
Route
CUTANEOUS
Published
Effective Date 2026-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Carbomer Aloe Barbadensis Leaf Juice Triethanolamine .alpha.-tocopherol Acetate Lecithin, Soybean Water Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-02-04

Description

Lidocaine 5%

Purpose

Anorectal (Hemorrhoidal)


Medication Information

Purpose

Anorectal (Hemorrhoidal)

Description

Lidocaine 5%

Uses

For temporary relief of local itching and discomfort Associated with anorectal disorders

Warnings

For external use only.

If condition worsens or does not improve within 7 days, consult a doctor.

Do not exceed the recommended daily dosage unless directed by a doctor.

Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

82929 011

Directions



Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.

Children under 12 years of age: consult a doctor.

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

Active Ingredient

Lidocaine 5%

Other Information

Store at room temperature (59-86 *F/15-30℃ ).

Keep away from direct sunlight or heat.

Keep out the reach of children. The package is child-resistant.

Do not use this product if seal is broken or missing

In case of accidental overdose and ingestion, call a doctor immediately.

Inactive Ingredients

Aloe barbadebsis lesf juice (Aloe vera), Water, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate, Carbomer, Triethanolamine

Keep Out of Reach of Children

if ​swallowed get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

For temporary relief of local itching and discomfort Associated with anorectal disorders

Purpose

Anorectal (Hemorrhoidal)

Warnings

For external use only.

If condition worsens or does not improve within 7 days, consult a doctor.

Do not exceed the recommended daily dosage unless directed by a doctor.

Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

82929 011 (82929-011)

Directions



Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.

Children under 12 years of age: consult a doctor.

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

Active Ingredient (Active ingredient)

Lidocaine 5%

Other Information

Store at room temperature (59-86 *F/15-30℃ ).

Keep away from direct sunlight or heat.

Keep out the reach of children. The package is child-resistant.

Do not use this product if seal is broken or missing

In case of accidental overdose and ingestion, call a doctor immediately.

Inactive Ingredients (Inactive ingredients)

Aloe barbadebsis lesf juice (Aloe vera), Water, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate, Carbomer, Triethanolamine

Keep Out of Reach of Children (Keep out of reach of children)

if ​swallowed get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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