Dosage and administration
Adults and children 2 years and older: apply externally to the affected area up to 3-4 times a day. Children under 2 years of age: consult a doctor
Lidocaine 4% Topical Anesthetic Cream
- Manufacturer
- Mohnark Pharmaceuticals Inc.
- Effective date
- 2025-07-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:08:03
Label at a glance#
ProductLidocaine 4% Topical Anesthetic Cream
Active ingredientLIDOCAINE
Label structure12 sections
Storage and handling
Store at USP controlled room temperature 20-25 o C (68-77 o F).
Label contents#
Full prescribing information#
Active Ingredients
Lidocaine 4% w/w
Purpose
Topical Anesthetic
Uses temporarily relieves pain and itching due to:
- minor cuts
- minor scrapes
- sunburn
- minor skin irritations
- minor burns
- insect bites
Warnings
For external use only
When using this product
- do not use in or near the eyes
- do not use in large quantities, particularly over raw surfaces or blistered areas
Stop use and ask a 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
Keep out of reach of children
if swallowed, get medical help or contact a Poison Control Center right away
Directions
- Adults and children 2 years and older: apply externally to the affected area up to 3-4 times a day.
- Children under 2 years of age: consult a doctor
Other information
- Store at USP controlled room temperature 20-25 oC (68-77 oF).
Inactive ingredients
benzyl alcohol, cabomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water
Dosage
40 milligrams/gram per application
Usage
- Adults and children 2 years and older: apply externally to the affected area up to 3-4 times a day.
- Children under 2 years of age: consult a doctor
Package Label
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73715-001-01 | Lidocaine 4% Topical Anesthetic Cream | 30 g in 1 TUBE | CREAM | 30 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 73715-001-01 | GM - Gram | 73715-001 | 4aa19057-e2f5-4ce7-a85a-5a297eac297e | 1 | 2024-04-05 |
Products#
Every source-derived product name is available through these pages.
- Lidocaine 4% Topical Anesthetic Cream
- Lidocaine 4% Cream
- POLYSORBATE 80
- LIDOCAINE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 73715-001 | 73715-001-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| LIDOCAINE | 98PI200987 | ACTIB |
| WATER | 059QF0KO0R | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 3a5f9898-0e6b-0b66-e063-6394a90a04b9 | a70863f0-48c1-5e6f-e053-2995a90a9606 | 2025-07-20 | Warnings | 3a5f9898-0e6b-0b66-e063-6394a90a04b9 a70863f0-48c1-5e6f-e053-2995a90a9606 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.