85150-007

85150-007
SPL v1
SPL
SPL Set ID 3385cddb-609f-62e8-e063-6294a90add81
Route
TOPICAL
Published
Effective Date 2025-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Smilax Glabra Tuber Caprylhydroxamic Acid Glycerin Cetearyl Alcohol Water Ethylhexyl Palmitate Zanthoxylum Bungeanum Fruit Benzyl Alcohol Carbomer Propylene Glycol .alpha.-tocopherol Acetate Menthol Turmeric Dendrobium Officinale Stem Stephania Tetrandra Root Salvia Miltiorrhiza Root Soybean Oil Glycyrrhiza Glabra Whole Phenoxyethanol Emu Oil Paeonol Aesculus Hippocastanum Leaf Taxus Cuspidata Leaf Arnica Montana

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-24

Description

Lidocaine 4%

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Lidocaine 4%

Use

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

Stop Use

• 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

Warnings

For external use only

Ask Doctor

if pregnant or breastfeeding

Directions

When practical, clean the area with mild soap and warm water and rinse thoroughly.

Gently dry by patting or bloating with toilet tissue or a soft cloth before applying.

a 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.

use finger cots: roll one finger cot over the finger. Gently squeeze cream on to the finger cot. Smooth a layer of the cream.

Do Not Use

if packaging has been breached or is missing.

When Using

• Do not get into the 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.

Active Ingredient

Lidocaine 4%

Other Information

Store at room temperature. Avoid direct sunlight. Do not use if tamper-evident packaging has been breached or is missing.

Inactive Ingredients

Water, Ethylhexyl Palmitate, Glycerin, Propylene Glycol, Benzyl Alcohol, Carbomer, Emu Oil, Lecithin, Tocopheryl Acetate, Cetyl Alcohol, Zanthoxylum Bungeanum Fruit Extract, Menthol, Paeonia Suffruticosa Root, Mentha Piperita Oil, Dendrobium Officinale Stem, Stephania Tetrandra Root, Aesculus Hippocastanum Extract, Taxus Cuspidata Leaf Extract, Arnica Montana Flower Extract, Smilax Glabra Tuber, Glycyrrhiza Glabra Root Extract, Caprylyl Glycol, Phenoxyethanol.

Principal Display Panel

Keep Oot of Reach of Children

If swallowed, get medical help.


Structured Label Content

Use

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

Purpose

Local Anesthetic

Stop Use

• 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

Warnings

For external use only

Ask Doctor

if pregnant or breastfeeding

Directions

When practical, clean the area with mild soap and warm water and rinse thoroughly.

Gently dry by patting or bloating with toilet tissue or a soft cloth before applying.

a 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.

use finger cots: roll one finger cot over the finger. Gently squeeze cream on to the finger cot. Smooth a layer of the cream.

Do Not Use (Do not use)

if packaging has been breached or is missing.

When Using

• Do not get into the 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.

Active Ingredient

Lidocaine 4%

Other Information (Other information)

Store at room temperature. Avoid direct sunlight. Do not use if tamper-evident packaging has been breached or is missing.

Inactive Ingredients (Inactive ingredients)

Water, Ethylhexyl Palmitate, Glycerin, Propylene Glycol, Benzyl Alcohol, Carbomer, Emu Oil, Lecithin, Tocopheryl Acetate, Cetyl Alcohol, Zanthoxylum Bungeanum Fruit Extract, Menthol, Paeonia Suffruticosa Root, Mentha Piperita Oil, Dendrobium Officinale Stem, Stephania Tetrandra Root, Aesculus Hippocastanum Extract, Taxus Cuspidata Leaf Extract, Arnica Montana Flower Extract, Smilax Glabra Tuber, Glycyrrhiza Glabra Root Extract, Caprylyl Glycol, Phenoxyethanol.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

If swallowed, get medical help.


Advanced Ingredient Data


Raw Label Data

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