3ffc57c7-5bf4-cba8-e063-6394a90a322f

SPL v1
SPL
SPL Set ID 3ffc57c7-5bf4-cba8-e063-6394a90a322f
Route
topical
Published
Effective Date 2025-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (5 g)
Inactive Ingredients
glycerin butylene glycol sodium hyaluronate tocopherol shea butter water menthol aloe centella asiatica simmondsia chinensis (jojoba) seed oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-09-30

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

For adults and children aged 12 and older: 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.

For children under 12: Consult a doctor

Purpose

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

Inactive Ingredients

WATER 65%

GLYCERIN 2%

BUTYLENE GLYCOL 5%

SODIUM HYALURONATE 0.1%

SHEABUTTER OIL 2%

SIMMONDSIA CHINENSIS SEED OIL 2%

TOCOPHEROL 0.5%

MENTHOL 2%

CENTELLA ASIATICA 0.5%

ALOE 0.5%

Description

LIDOCAINE 5%

Principal Display Panel

Stop Use

Stop use and ask a doctor if rash occurs.

Do Not Use

on damaged or broken skin.

When Using

When using this product keep out of eyes. Rinse with water to remove.

Active Ingredients

LIDOCAINE 5%

Dosage & Administration

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

Keep Out of Reach of Children

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


Structured Label Content

Warnings

For external use only

Uses

For adults and children aged 12 and older: 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.

For children under 12: Consult a doctor

Purpose

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

Inactive Ingredients (Inactive ingredients)

WATER 65%

GLYCERIN 2%

BUTYLENE GLYCOL 5%

SODIUM HYALURONATE 0.1%

SHEABUTTER OIL 2%

SIMMONDSIA CHINENSIS SEED OIL 2%

TOCOPHEROL 0.5%

MENTHOL 2%

CENTELLA ASIATICA 0.5%

ALOE 0.5%

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Stop Use

Stop use and ask a doctor if rash occurs.

Do Not Use

on damaged or broken skin.

When Using

When using this product keep out of eyes. Rinse with water to remove.

Active Ingredients

LIDOCAINE 5%

Dosage & Administration (Dosage & administration)

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

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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