SPL v1
SPL
SPL Set ID 43a65a12-ef2a-4608-e063-6394a90a82ea
Route
TOPICAL
Published
Effective Date 2026-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.15 g)
Inactive Ingredients
Chlorphenesin Glycerin Caprylic/capric/lauric Triglyceride Phenoxyethanol Arginine .alpha.-tocopherol Acetate, D- Water Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Propylene Glycol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-15

Description

(For external use only) When using this product: Avoid contact with eyes. Do not exceed recommended dosage unless directed by a doctor. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if: Rectal bleeding occurs. Condition worsens or does not improve within 7 days. Allergic reaction occurs to ingredients in this product. Symptom being treated does not subside or if redness irritation, swelling, pain or other symptoms develop or increase symptoms clear up and return within a few days. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Medication Information

Indications and Usage

Uses

Helps relieve the pain, itching and burning associated with

hemorrhoids and other anorectal disorders.

Avoid contact with eyes.

Do not exceed recommended dosage unless directed

by a doctor.

Do not put this product into the rectum by using fingers

or any mechanical device or applicator.

Stop use and ask a doctor if:

Rectal bleeding occurs.

Condition worsens or does not improve within 7 days.

Allergic reaction occurs to ingredients in this product.

Symptom being treated does not subside or if redness

irritation, swelling, pain or other symptoms develop or

increase symptoms clear up and return within a few days.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

Dosage and Administration

Directions

When practical, clean area with mild soap and warm

water and rinse thoroughly. Gently dry by patting or

blotting with toilet tissue or soft cloth before applying.

Adults and children 12 years and older:

apply externally to the affected area up to 6 times a day.

For the temporary relief of pain and discomfort associated with anorectal disorders.

Description

(For external use only) When using this product: Avoid contact with eyes. Do not exceed recommended dosage unless directed by a doctor. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if: Rectal bleeding occurs. Condition worsens or does not improve within 7 days. Allergic reaction occurs to ingredients in this product. Symptom being treated does not subside or if redness irritation, swelling, pain or other symptoms develop or increase symptoms clear up and return within a few days. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Hydroxyethyl Acrylate/

Sodium Acryloyldimethyl Taurate Copolymer, Caprylic/

Capric Triglyceride, Tocopheryl Acetate, Arginine,

Phenoxyethanol, Chlorphenesin

Section 55105-1

Local anesthetic

Section 55106-9

Lidocaine 4%.

Warnings

(For external use only)

When using this product:

Avoid contact with eyes.

Do not exceed recommended dosage unless directed

by a doctor.

Do not put this product into the rectum by using fingers

or any mechanical device or applicator.

Stop use and ask a doctor if:

Rectal bleeding occurs.

Condition worsens or does not improve within 7 days.

Allergic reaction occurs to ingredients in this product.

Symptom being treated does not subside or if redness

irritation, swelling, pain or other symptoms develop or

increase symptoms clear up and return within a few days.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

Drug Facts

DRUG FACTS

Active Ingredient

Lidocaine 4%.

Uses

Helps relieve the pain, itching and burning associated with

hemorrhoids and other anorectal disorders.

Warnings (For external use only)

When using this product:

Avoid contact with eyes.

Do not exceed recommended dosage unless directed

by a doctor.

Do not put this product into the rectum by using fingers

or any mechanical device or applicator.

Stop use and ask a doctor if:

Rectal bleeding occurs.

Condition worsens or does not improve within 7 days.

Allergic reaction occurs to ingredients in this product.

Symptom being treated does not subside or if redness

irritation, swelling, pain or other symptoms develop or

increase symptoms clear up and return within a few days.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

Purpose

Local anesthetic

DRUG FACTS (Continued)

Directions

When practical, clean area with mild soap and warm

water and rinse thoroughly. Gently dry by patting or

blotting with toilet tissue or soft cloth before applying.

Adults and children 12 years and older:

apply externally to the affected area up to 6 times a day.

Children under 12 years of age: Consult a doctor.

To use finger cots: Roll one finger cot over finger.

Gently squeeze cream onto finger cot. Smooth a layer

of the cream over affected area.

Other Information

Store at 25°C (77°F); excursions permitted to 15-30C

(59-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Hydroxyethyl Acrylate/

Sodium Acryloyldimethyl Taurate Copolymer, Caprylic/

Capric Triglyceride, Tocopheryl Acetate, Arginine,

Phenoxyethanol, Chlorphenesin

No Change Yet

No change yet

Pregnancy Section

Consult your doctor before using it


Structured Label Content

Indications and Usage (34067-9)

Uses

Helps relieve the pain, itching and burning associated with

hemorrhoids and other anorectal disorders.

Avoid contact with eyes.

Do not exceed recommended dosage unless directed

by a doctor.

Do not put this product into the rectum by using fingers

or any mechanical device or applicator.

Stop use and ask a doctor if:

Rectal bleeding occurs.

Condition worsens or does not improve within 7 days.

Allergic reaction occurs to ingredients in this product.

Symptom being treated does not subside or if redness

irritation, swelling, pain or other symptoms develop or

increase symptoms clear up and return within a few days.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

Dosage and Administration (34068-7)

Directions

When practical, clean area with mild soap and warm

water and rinse thoroughly. Gently dry by patting or

blotting with toilet tissue or soft cloth before applying.

Adults and children 12 years and older:

apply externally to the affected area up to 6 times a day.

For the temporary relief of pain and discomfort associated with anorectal disorders.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Hydroxyethyl Acrylate/

Sodium Acryloyldimethyl Taurate Copolymer, Caprylic/

Capric Triglyceride, Tocopheryl Acetate, Arginine,

Phenoxyethanol, Chlorphenesin

Section 55105-1 (55105-1)

Local anesthetic

Section 55106-9 (55106-9)

Lidocaine 4%.

Warnings

(For external use only)

When using this product:

Avoid contact with eyes.

Do not exceed recommended dosage unless directed

by a doctor.

Do not put this product into the rectum by using fingers

or any mechanical device or applicator.

Stop use and ask a doctor if:

Rectal bleeding occurs.

Condition worsens or does not improve within 7 days.

Allergic reaction occurs to ingredients in this product.

Symptom being treated does not subside or if redness

irritation, swelling, pain or other symptoms develop or

increase symptoms clear up and return within a few days.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

Drug Facts (DRUG FACTS)

DRUG FACTS

Active Ingredient

Lidocaine 4%.

Uses

Helps relieve the pain, itching and burning associated with

hemorrhoids and other anorectal disorders.

Warnings (For external use only)

When using this product:

Avoid contact with eyes.

Do not exceed recommended dosage unless directed

by a doctor.

Do not put this product into the rectum by using fingers

or any mechanical device or applicator.

Stop use and ask a doctor if:

Rectal bleeding occurs.

Condition worsens or does not improve within 7 days.

Allergic reaction occurs to ingredients in this product.

Symptom being treated does not subside or if redness

irritation, swelling, pain or other symptoms develop or

increase symptoms clear up and return within a few days.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

Purpose

Local anesthetic

DRUG FACTS (Continued)

Directions

When practical, clean area with mild soap and warm

water and rinse thoroughly. Gently dry by patting or

blotting with toilet tissue or soft cloth before applying.

Adults and children 12 years and older:

apply externally to the affected area up to 6 times a day.

Children under 12 years of age: Consult a doctor.

To use finger cots: Roll one finger cot over finger.

Gently squeeze cream onto finger cot. Smooth a layer

of the cream over affected area.

Other Information

Store at 25°C (77°F); excursions permitted to 15-30C

(59-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Hydroxyethyl Acrylate/

Sodium Acryloyldimethyl Taurate Copolymer, Caprylic/

Capric Triglyceride, Tocopheryl Acetate, Arginine,

Phenoxyethanol, Chlorphenesin

No Change Yet (No change yet)

No change yet

Pregnancy Section

Consult your doctor before using it


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)