Drug Facts

Drug Facts

SPL v7

SPL

SPL Set ID 0578fbcb-875a-4606-acde-dcecb29756e6

Route

TOPICAL

Published

Effective Date 2020-07-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Lidocaine (1.2 g)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-10-12

Description

Lidocaine 4% w/w

Purpose

Topical Anesthetic

Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4% w/w

Uses

Temporarily relieves pain and itching due to

insect bites
minor burns
minor cuts
minor scrapes
minor skin irritations
sunburn

Warnings

For external use only

Directions

Adults and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day
Children under 2 years: Consult a doctor

Active Ingredient

Lidocaine 4% w/w

Other Information

May be applied under occlusive dressing.
Store at 25 ̊C (77 ̊F);
excursions permitted to 15°C -30°C (59°F - 86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

Benzyl Alcohol, Carbopol, Lecithin(Soybean), 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 69903-003-30

Water-based, Hypoallergenic and Fast Penetrating Topical Pain Relief and Anti-Itch Formula

Apply to the skin to relieve pain

FOR EXTERNAL USE ONLY

Dr. Numb

TOPICAL ANESTHETIC CREAM

Lidocaine 4% Cream - Topical Anesthetic

30g

When Using This Product

avoid contact with the eyes
do not use in large quantities, particularly over raw surfaces or blistered areas

Keep Our 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
condition worsens or does not improve within 7 days
symptoms clear up and return within a few days
redness, irritation, swelling, pain or other symptoms begin or increase

Structured Label Content

Uses

Temporarily relieves pain and itching due to

insect bites
minor burns
minor cuts
minor scrapes
minor skin irritations
sunburn

Purpose

Topical Anesthetic

Warnings

For external use only

Directions

Adults and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day
Children under 2 years: Consult a doctor

Active Ingredient (Active ingredient)

Lidocaine 4% w/w

Other Information

May be applied under occlusive dressing.
Store at 25 ̊C (77 ̊F);
excursions permitted to 15°C -30°C (59°F - 86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

Benzyl Alcohol, Carbopol, Lecithin(Soybean), 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 69903-003-30

Water-based, Hypoallergenic and Fast Penetrating Topical Pain Relief and Anti-Itch Formula

Apply to the skin to relieve pain

FOR EXTERNAL USE ONLY

Dr. Numb

TOPICAL ANESTHETIC CREAM

Lidocaine 4% Cream - Topical Anesthetic

30g

When Using This Product (When using this product)

avoid contact with the eyes
do not use in large quantities, particularly over raw surfaces or blistered areas

Keep Our of Reach of Children (KEEP OUR 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
condition worsens or does not improve within 7 days
symptoms clear up and return within a few days
redness, irritation, swelling, pain or other symptoms begin or increase

Advanced Ingredient Data

[{"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": "1.2", "strengthDenominator": "30", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"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": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily relieves pain and itching due to insect bites minor burns minor cuts minor scrapes minor skin irritations sunburn", "Purpose": "Topical Anesthetic", "Warnings": "For external use only", "Directions": "Adults and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day Children under 2 years: Consult a doctor", "Active ingredient": "Lidocaine 4% w/w", "Other Information": "May be applied under occlusive dressing. Store at 25 ̊C (77 ̊F); excursions permitted to 15°C -30°C (59°F - 86°F) [see USP Controlled Room Temperature].", "Inactive Ingredients": "Benzyl Alcohol, Carbopol, Lecithin(Soybean), 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 69903-003-30 Water-based, Hypoallergenic and Fast Penetrating Topical Pain Relief and Anti-Itch Formula Apply to the skin to relieve pain FOR EXTERNAL USE ONLY Dr. Numb TOPICAL ANESTHETIC CREAM Lidocaine 4% Cream - Topical Anesthetic 30g", "When using this product": "avoid contact with the eyes do not use in large quantities, particularly over raw surfaces or blistered areas", "KEEP OUR 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 condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:55.766649 · Updated: 2026-03-14T23:02:45.179164