SPL v1
SPL
SPL Set ID 3cba84ea-5ee0-7ee3-e063-6294a90af11b
Route
TOPICAL
Published
Effective Date 2025-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Purslane Peg-40 Hydrogenated Castor Oil Prilocaine Aqua Propylene Glycol Carbomer Glycerin Mentha Arvensis Leaf Chrysanthellum Indicum Top Tetracaine Edetate Disodium Hydroxyacetophenone 1,2-hexanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-19

Description

Lidocaine 5.00 % Anorectal (hemorrhoidal)


Medication Information

Warnings and Precautions

Warnings:For external use only

Indications and Usage

When using this product m lf the condition worsens or does not improve within 7days, consult a doctor. m In case of bleeding, consult a doctor promptly.

Dosage and Administration

Directions:

Adults: m When practical, cleanse the affected area “with mild soap and warm waterand rinse by patting or blotting with an appropriate cleansing padGently dry by patting or blotting with toilet tissue or a soft cloth before application ofthis product.

Children under 12 years of age: consult a doctor.Apply externally to the affected area up to 6 times daily or after each bowelmovement.

Description

Lidocaine 5.00 % Anorectal (hemorrhoidal)

Section 50565-1

Keep out of reach of children.

lf swallowed, get medical help or contact a Poison Control Center right away.If pregnant or breast-feeding, ask a health professional before use

Section 51727-6

Inactive ingredients: Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua(Deionized Water), Benzy Alcohol, Carbomer, Dimethyl lsosorbide, Ethylhexylglycerin,.Ethylhexyl Stearate, Hydrogenated Polyisobutene, Lecithin, Phenoxyethanol,Propylene Glycol, Sodium Polyacrylate, Tetrasodium EDTA, Tocopheryl Acetate(Vitamin E), Trideceth-6

Section 51945-4

Section 55105-1

Helps relieve the local itching and discomfort in the perianal area m For thetemporary relief of pain, irritation" or burning.

Section 55106-9

Lidocaine 5.00 %

Anorectal (hemorrhoidal)

Section 60561-8

Other information:Protect the product in this container from excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)

When using this product m lf the condition worsens or does not improve within 7days, consult a doctor. m In case of bleeding, consult a doctor promptly.

Dosage and Administration (34068-7)

Directions:

Adults: m When practical, cleanse the affected area “with mild soap and warm waterand rinse by patting or blotting with an appropriate cleansing padGently dry by patting or blotting with toilet tissue or a soft cloth before application ofthis product.

Children under 12 years of age: consult a doctor.Apply externally to the affected area up to 6 times daily or after each bowelmovement.

Warnings and Precautions (34071-1)

Warnings:For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

lf swallowed, get medical help or contact a Poison Control Center right away.If pregnant or breast-feeding, ask a health professional before use

Section 51727-6 (51727-6)

Inactive ingredients: Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua(Deionized Water), Benzy Alcohol, Carbomer, Dimethyl lsosorbide, Ethylhexylglycerin,.Ethylhexyl Stearate, Hydrogenated Polyisobutene, Lecithin, Phenoxyethanol,Propylene Glycol, Sodium Polyacrylate, Tetrasodium EDTA, Tocopheryl Acetate(Vitamin E), Trideceth-6

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps relieve the local itching and discomfort in the perianal area m For thetemporary relief of pain, irritation" or burning.

Section 55106-9 (55106-9)

Lidocaine 5.00 %

Anorectal (hemorrhoidal)

Section 60561-8 (60561-8)

Other information:Protect the product in this container from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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