Indications and uses
For the temporarily relief of pain and itching associated with: •minor burns •sunburn •minor cuts •scrapes •insect bites •minor skin irritations •rashes due to poison ivy, poison oak, or poison sumac.
NDC 59088-241 Lidocaine 3% Cream
- Manufacturer
- PureTek Corporation
- Effective date
- 2025-08-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:10:04
Label at a glance#
ProductLidocaine 3%
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections
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: do not use, consult a licensed healthcare practitioner.
Storage and handling
• Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]
Label contents#
Full prescribing information#
Active Ingredient
Lidocaine HCl 3%
Purpose
Topical Analgesic
Uses
For the temporarily relief of pain and itching associated with:
•minor burns •sunburn •minor cuts •scrapes •insect bites •minor skin irritations •rashes due to poison ivy, poison oak, or poison sumac.
Warnings
• For External Use Only
When using this product:
•Avoid contact with the eyes. •Do not use in large quantities, particularly over raw surfaces or blistered areas.
Stop use and ask a doctor if
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a licensed healthcare practitioner.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
• Keep this and all other drugs out of the reach of children.
Directions:
• 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: do not use, consult a licensed healthcare practitioner.
Other information
• Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]
Inactive ingredients:
Aqua (Purified Water), Calcium Acetate, Ceteareth-20, Cetearyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Petrolatum, Propylene Glycol, Propylparaben, Sodium Phosphate.
Lidocaine 3% Cream
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59088-241-07 | Lidocaine 3% | 85 g in 1 TUBE | CREAM | 85 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59088-241-07 | GM - Gram | 59088-241 | df888b11-d3b1-47cb-9aad-faa13fef8270 | 1 | 2025-09-12 |
Products#
Every source-derived product name is available through these pages.
- Lidocaine 3%
- Lidocaine HCl 3%
- MINERAL OIL
- CETEARYL ALCOHOL
- SODIUM PHOSPHATE
- PROPYLENE GLYCOL
- LIDOCAINE HYDROCHLORIDE
- LIDOCAINE
- LIDOCAINE HYDROCHLORIDE ANHYDROUS
- GLYCERIN
- WATER
- PROPYLPARABEN
- METHYLPARABEN
- PETROLATUM
- CALCIUM ACETATE
- CETEARETH-20
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59088-241 | 59088-241-07 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MINERAL OIL | T5L8T28FGP | IACT |
| CETEARYL ALCOHOL | 2DMT128M1S | IACT |
| SODIUM PHOSPHATE | SE337SVY37 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| LIDOCAINE HYDROCHLORIDE | V13007Z41A | ACTIR |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| CALCIUM ACETATE | Y882YXF34X | IACT |
| CETEARETH-20 | YRC528SWUY | 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 |
|---|---|---|---|---|---|---|
| Lidocaine 3% | LIDOCAINE HCL 3% | PureTek Corporation | 3bc94d52-fe52-9fd6-e063-6294a90a4340 | 2025-08-12 | Warnings | 59088-241-07 59088-241 59088024107 3bc94d52-fe52-9fd6-e063-6294a90a4340 3bc94d52-fe52-9fd6-e063-6294a90a4340 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.