Dosage and administration
Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor
Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor
LIDOCAINE 4%- lidocaine cream
MarlexPharmaceuticals, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Lidocaine 4% Topical
Drug Facts
Lidocaine 4%
Pain & Itch Relief
for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations
For external use only. Avoid contact with eyes. Not for prolonged use.
Donotusein large quantities, particularly over raw surfaces or blistered areas.
ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away
Adults and children 2 years of age and older:apply to affected area not more than 3 to 4 times daily
Children under 2 years of age:Consult a doctor
Benzyl alcohol, carbomer, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water, trolamine and vitamin E acetate
Lidocaine 4% Topical Anesthetic Cream
Pain & Itch Relief Cream NET WT. 0.5 oz.(15g)
Lidocaine 4% Topical Anesthetic Cream
Pain & Itch Relief Cream NET WT. (30g)
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 070fbed5-7088-434a-a7ce-f2a64d8d40ac | Product name | 2 | 20260107 |
| bee66ce1-adb7-9d3b-67d9-582e4c54e80f | Product name | 5 | 20250819 |
| 860a93dc-4863-49cc-b284-6bbe8191bc48 | Product name | 4 | 20250214 |
| eaba870a-6a9d-442e-8643-87b3f558a451 | Product name | 1 | 20250117 |
| 9b4cf230-fd05-41d5-98c6-5db9ecb27b86 | Product name | 1 | 20230117 |
| 7d755fa1-1087-4dcd-98f0-6d4bba479a57 | Product name | 3 | 20210602 |
| aed701d5-9c75-dfaf-7154-cde46179faea | Product name | 9 | 20200313 |
| fa8b5901-e681-426f-82fe-54f6d81ec698 | Product name | 4 | 20180619 |
| 332d03e4-aa24-4b11-841a-02bf41081920 | Product name | 1 | 20171221 |
| c08ab52f-2fc8-4409-9d9f-ed8edc0bd070 | Product name | 1 | 20171221 |
| 68ed98f8-24c2-44a0-944a-6d36e82ce25a | Product name | 1 | 20141222 |
| 1cd42bc2-a430-c72b-636d-991b235fbf80 | Product name | 1 | 20140508 |
| 49fa150c-f0de-cce7-3d9c-993ed81c5698 | Product name | 1 | 20140508 |
| 4d7ae718-ed00-bae8-2abe-9eaec1eef7ff | Product name | 1 | 20140508 |
| 9137811f-f279-8640-5aeb-99fa2145d64d | Product name | 1 | 20140508 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10135-672-96 | Lidocaine | 1 in 1 CARTON | CREAM | 1 | 7 | |
| 10135-672-96 | Lidocaine | 15 g in 1 TUBE | CREAM | 15 | 7 | |
| 10135-672-99 | Lidocaine | 30 g in 1 TUBE | CREAM | 30 | 7 | |
| 10135-672-99 | Lidocaine | 1 in 1 CARTON | CREAM | 1 | 7 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10135-672-96 | GM - Gram | 10135-672 | 6ac4621f-45be-4467-b56b-cbe027135c25 | 1 | 2019-01-24 |
| 10135-672-99 | GM - Gram | 10135-672 | 6d200e7a-361c-40bb-b4ff-918da3997e3f | 1 | 2019-01-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 10135-672 | 10135-672-96, 10135-672-99 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | IACT |
| CHOLESTEROL | 97C5T2UQ7J | IACT |
| HYDROGENATED SOYBEAN LECITHIN | H1109Z9J4N | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| ALPHA-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| WATER | 059QF0KO0R | IACT |
| LIDOCAINE | 98PI200987 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Lidocaine | LIDOCAINE | Marlex Pharmaceuticals Inc | 4de2bc60-dc4a-4417-984f-eabab0e926a6 | 2025-11-14 | Warnings | 10135-672-96 10135-672-99 10135-672 10135067296 10135067299 4391728b-dfe1-3ffb-e063-6394a90a240e 4de2bc60-dc4a-4417-984f-eabab0e926a6 |
Adverse event summaries are temporarily unavailable. Other product information remains available.