SPL v1
SPL
SPL Set ID 45a93832-7678-ad5c-e063-6294a90a3230
Route
TOPICAL
Published
Effective Date 2025-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging

Description

For external use only.

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Adults and children 12 years and older: When practical, cleanse theaffected 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. Apply a thin layer of cream to the affected area up to 6 times daily as needed. Children under 12 years: Consult a doctor.

Dosage and Administration

Adults and children 12 years and older: Apply a thin layer to the affected area 1-3 times daily or as directed by a healthcare provider.

Description

For external use only.

Section 50565-1

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

Section 50566-9

Allergic reaction occurs. Rectal bleeding occurs. Condition worsens or does not improve within 7 days. Redness, irritation, sweling, pain, or other symptoms begin or increase.

Section 50567-7

Do not exceed the recommended daily dosage unless directed by adoctor Do not insert into the rectum using fingers or any mechanical device orapplicator

Section 51727-6

Water, Propylene Glycol, Glycerin, Carbomer, Disodium EDTA, Hydroxyacetophenone, 1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Mentha Arvensis Leaf Extract, Chrysanthellum Indicum Extract, Portulaca Oleracea Extract,Tocopheryl Acetate.

Section 51945-4

1

Section 55105-1

Anorectal (Hemorrhoidal)

Section 55106-9

5% Lidocaine

Structured Label Content

Indications and Usage (34067-9)

Adults and children 12 years and older: When practical, cleanse theaffected 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. Apply a thin layer of cream to the affected area up to 6 times daily as needed. Children under 12 years: Consult a doctor.

Dosage and Administration (34068-7)

Adults and children 12 years and older: Apply a thin layer to the affected area 1-3 times daily or as directed by a healthcare provider.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Allergic reaction occurs. Rectal bleeding occurs. Condition worsens or does not improve within 7 days. Redness, irritation, sweling, pain, or other symptoms begin or increase.

Section 50567-7 (50567-7)

Do not exceed the recommended daily dosage unless directed by adoctor Do not insert into the rectum using fingers or any mechanical device orapplicator

Section 51727-6 (51727-6)

Water, Propylene Glycol, Glycerin, Carbomer, Disodium EDTA, Hydroxyacetophenone, 1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Mentha Arvensis Leaf Extract, Chrysanthellum Indicum Extract, Portulaca Oleracea Extract,Tocopheryl Acetate.

Section 51945-4 (51945-4)

1

Section 55105-1 (55105-1)

Anorectal (Hemorrhoidal)

Section 55106-9 (55106-9)

5% Lidocaine

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:36.783020 · Updated: 2026-02-15T12:07:36.736833