OTC - ACTIVE INGREDIENT SECTION
Lidocaine HCl 4%
Menthol 1%
Lidocaine HCl 4%
Menthol 1%
benzyl alcohol, carbomer, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water triethanolamine, vitamin E
Adults and children 12 years and older: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 to 4 applications in a 24-hour period.
BEFORE AND AFTER APPLYING, WASH HANDS WITH SOAP AND WATER.
Children under 12 years: ask a doctor
temporary relieves minor pain
For external use only
Do not use on large areas of the body or on cut, irritated or swollen skin, on puncture wounds, for more than one week without consulting a doctor.
When using this product use only as directed. Read and follow all directions and warnings on this label, rare cases of serious burns have been reported with products of this type, do not bandage or apply local heat (such as heating pads) to the area of use or use with a medicated, avoid contact with eyes and mucous membranes, a transient burning sensation may occur upon application but generally disappears in several days.
Stop use and ask a doctor if condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days or clear up and occur again within a few days, you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children and pets.
If swallowed, get medical help or contact a Poison Control Center right away.
Topical anesthetic
Topical analgesic
NDC: 69729-452-72 Calmadrazos
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69729-452-72 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-acd8-d83d-e063-dadaa90ab31f | CalmaDrazos Lidocaine HCl 4% and Menthol 1% |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69729-452-72 | Lidocaine HCl 4% Menthol 1% | 76.6 g in 1 PACKAGE | OINTMENT | 76.6 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69729-452 | 69729-452-72 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| HYDROGENATED SOYBEAN LECITHIN | H1109Z9J4N | IACT |
| WATER | 059QF0KO0R | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| CARBOMER 940 | 4Q93RCW27E | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| LIDOCAINE | 98PI200987 | ACTIB |
| MENTHOL | L7T10EIP3A | 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 |
|---|---|---|---|---|---|---|
| e11cc0b1-b375-6f1f-e053-2995a90a1e40 | b9cf255a-6e36-8a75-e053-2995a90af5ea | 2022-06-10 | Warnings | e11cc0b1-b375-6f1f-e053-2995a90a1e40 b9cf255a-6e36-8a75-e053-2995a90af5ea |
Adverse event summaries are temporarily unavailable. Other product information remains available.