Drug Facts

Drug Facts

SPL v7

SPL

SPL Set ID 32ab24b4-dcec-4a09-e054-00144ff88e88

Route

TOPICAL

Published

Effective Date 2020-07-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Lidocaine (1.5 g)

Inactive Ingredients

Benzyl Alcohol Carbomer Homopolymer, Unspecified Type Lecithin, Soybean Propylene Glycol Butyl Ether Tocopheryl Retinoate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-07-01

Description

Lidocaine 5%

Purpose

Anorectal (Hemmorhoidal)

Medication Information

Purpose

Anorectal (Hemmorhoidal)

Description

Lidocaine 5%

Uses

For temporary relief of local discomfort, itching, pain, soreness or burning in the perianal area associated with anorectal disorders.

Warnings

For external use only

Directions

Adults and Children 12 years and older: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application of product. Apply to the affected area upto 6 times a day
Children under 12 years of age: Consult a doctor

Active Ingredient

Lidocaine 5%

Other Information

always keep the tube tightly closed
store at temperature not exceeding 15 ^°C - 30 ^°C (59°F - 86°F)
protect from freezing

Inactive Ingredients

Benzyl Alcohol, Carbopol, Lecithin, Propylene Glycol, Tocopheryl Acetate, Water.

Question Or Comments

Contact our dedicated Customer Care at 1-877-786-2001 or email us at [email protected]

Principal Display Panel

NDC 69903-001-30

Prompt, Soothing Relief from Painful Burning, Itching and Discomfort

5% Lidocaine Cream

For External Use Only

Dr. Numb Lidocaine Cream

RAPID ABSORPTION

Maximum Strength Pain Reliever

30g

When Using This Product

do not exceed the recommended daily dosage unless directed by a doctor
do not put into the rectum by using fingers or any mechanical device or applicator

Keep Out of Reach of Children

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

Stop the Use and Consult Doctor If

allergic reaction occurs
rectal bleeding occurs
redness, irritation, swelling, pain, or other symptoms begin or increase
condition worsens or does not improve within 7 days

Structured Label Content

Uses

For temporary relief of local discomfort, itching, pain, soreness or burning in the perianal area associated with anorectal disorders.

Purpose

Anorectal (Hemmorhoidal)

Warnings

For external use only

Directions

Adults and Children 12 years and older: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application of product. Apply to the affected area upto 6 times a day
Children under 12 years of age: Consult a doctor

Active Ingredient (Active ingredient)

Lidocaine 5%

Other Information (Other information)

always keep the tube tightly closed
store at temperature not exceeding 15 ^°C - 30 ^°C (59°F - 86°F)
protect from freezing

Inactive Ingredients

Benzyl Alcohol, Carbopol, Lecithin, Propylene Glycol, Tocopheryl Acetate, Water.

Question Or Comments (Question or comments)

Contact our dedicated Customer Care at 1-877-786-2001 or email us at [email protected]

Principal Display Panel

NDC 69903-001-30

Prompt, Soothing Relief from Painful Burning, Itching and Discomfort

5% Lidocaine Cream

For External Use Only

Dr. Numb Lidocaine Cream

RAPID ABSORPTION

Maximum Strength Pain Reliever

30g

When Using This Product (When using this product)

do not exceed the recommended daily dosage unless directed by a doctor
do not put into the rectum by using fingers or any mechanical device or applicator

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

Stop the Use and Consult Doctor If (Stop the use and consult doctor if)

allergic reaction occurs
rectal bleeding occurs
redness, irritation, swelling, pain, or other symptoms begin or increase
condition worsens or does not improve within 7 days

Advanced Ingredient Data

[{"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LECITHIN, SOYBEAN", "unii": "1DI56QDM62", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL BUTYL ETHER", "unii": "6X8776AP5Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHERYL RETINOATE", "unii": "0WN694NBMM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE", "unii": "98PI200987", "classCode": "ACTIB", "strengthNumerator": "1.5", "strengthDenominator": "30", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For temporary relief of local discomfort, itching, pain, soreness or burning in the perianal area associated with anorectal disorders.", "Purpose": "Anorectal (Hemmorhoidal)", "Warnings": "For external use only", "Directions": "Adults and Children 12 years and older: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application of product. Apply to the affected area upto 6 times a day Children under 12 years of age: Consult a doctor", "Active ingredient": "Lidocaine 5%", "Other information": "always keep the tube tightly closed store at temperature not exceeding 15 ° C - 30 ° C (59°F - 86°F) protect from freezing", "Inactive Ingredients": "Benzyl Alcohol, Carbopol, Lecithin, Propylene Glycol, Tocopheryl Acetate, Water.", "Question or comments": "Contact our dedicated Customer Care at 1-877-786-2001 or email us at support@shinpharma.com ", "Principal Display Panel": "NDC 69903-001-30 Prompt, Soothing Relief from Painful Burning, Itching and Discomfort 5% Lidocaine Cream For External Use Only Dr. Numb Lidocaine Cream RAPID ABSORPTION Maximum Strength Pain Reliever 30g", "When using this product": "do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator", "keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away", "Stop the use and consult doctor if": "allergic reaction occurs rectal bleeding occurs redness, irritation, swelling, pain, or other symptoms begin or increase condition worsens or does not improve within 7 days"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:55.779743 · Updated: 2026-03-14T23:02:45.179164