drug facts

drug facts

SPL v8

SPL

SPL Set ID 3ac18167-774b-3777-e054-00144ff8d46c

Route

topical

Published

Effective Date 2020-04-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

lidocaine (5 mg)

Inactive Ingredients

water carbomer 934 propylene glycol butyl ether tocopheryl retinoate benzyl alcohol lecithin, soybean

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2016-09-01

Purpose

Anorectal (Hemmorhoidal)

Description

Lidocaine 5%

Medication Information

Warnings

For external use only

Uses

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

Purpose

Anorectal (Hemmorhoidal)

Directions

Adults: 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.
when first opening the tube, puncture foil seal with top end of cap
apply externally to the affected area up to 6 times daily
children under 12 years of age: consult a doctor

Other Information

always keep the tube tightly closed
store at temperatures not exceeding 15 ^OC - 30 ^OC
protect from freezing

Description

Lidocaine 5%

Principal Display Panel

NDC 70907-001-15

FOR EXTERNAL USE ONLY

NumbSkin Cream ^®

5% Lidocaine Cream

Maximum Strength Pain Reliever

NET WT. 15g

NDC 70907-001-30

FOR EXTERNAL USE ONLY

NumbSkin Cream ^®

5% Lidocaine Cream

Maximum Strength Pain Reliever

NET WT. 30g

Active Ingredient

Lidocaine 5%

Inactive Ingrdients

Benzyl Alcohol, Carbomer 934, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate, Water

Question Or Comments

Call weekdays 9 AM to 6 PM PST at 1-844-700-6862 or email us at [email protected]

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 worsenss or does not improve within 7 days

Structured Label Content

Warnings

For external use only

Uses

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

Purpose

Anorectal (Hemmorhoidal)

Directions

Adults: 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.
when first opening the tube, puncture foil seal with top end of cap
apply externally to the affected area up to 6 times daily
children under 12 years of age: consult a doctor

Other Information (Other information)

always keep the tube tightly closed
store at temperatures not exceeding 15 ^OC - 30 ^OC
protect from freezing

Principal Display Panel

NDC 70907-001-15

FOR EXTERNAL USE ONLY

NumbSkin Cream ^®

5% Lidocaine Cream

Maximum Strength Pain Reliever

NET WT. 15g

NDC 70907-001-30

FOR EXTERNAL USE ONLY

NumbSkin Cream ^®

5% Lidocaine Cream

Maximum Strength Pain Reliever

NET WT. 30g

Active Ingredient

Lidocaine 5%

Inactive Ingrdients (Inactive ingrdients)

Benzyl Alcohol, Carbomer 934, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate, Water

Question Or Comments (Question or comments)

Call weekdays 9 AM to 6 PM PST at 1-844-700-6862 or email us at [email protected]

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 worsenss or does not improve within 7 days

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 934", "unii": "Z135WT9208", "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": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LECITHIN, SOYBEAN", "unii": "1DI56QDM62", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE", "unii": "98PI200987", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "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: 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. when first opening the tube, puncture foil seal with top end of cap apply externally to the affected area up to 6 times daily children under 12 years of age: consult a doctor", "Active Ingredient": "Lidocaine 5%", "Other information": "always keep the tube tightly closed store at temperatures not exceeding 15 O C - 30 O C protect from freezing", "Inactive ingrdients": "Benzyl Alcohol, Carbomer 934, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate, Water", "Question or comments": "Call weekdays 9 AM to 6 PM PST at 1-844-700-6862 or email us at support@numbskin.com", "Principal Display Panel": "NDC 70907-001-15 FOR EXTERNAL USE ONLY NumbSkin Cream ® 5% Lidocaine Cream Maximum Strength Pain Reliever NET WT. 15g NDC 70907-001-30 FOR EXTERNAL USE ONLY NumbSkin Cream ® 5% Lidocaine Cream Maximum Strength Pain Reliever NET WT. 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 worsenss or does not improve within 7 days"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:22.068643 · Updated: 2026-03-14T23:00:46.071932