Indications and uses
Temporarily relieves pain and itching due to minor cuts sunburn minor scrapes minor burns insect bites minor skin irritations
Lidocaine HCl 3% Topical Anesthetic Cream
- Manufacturer
- Brookfield Pharmaceuticals, LLC
- Effective date
- 2021-11-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:27:12
Label at a glance#
ProductLidocaine HCl
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure11 sections
Dosage and administration
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 ask a doctor
Label contents#
Full prescribing information#
Active Ingredient
Lidocaine HCl 3% w/w
Purpose
Topical anesthetic
Uses
Temporarily relieves pain and itching due to
- minor cuts
- sunburn
- minor scrapes
- minor burns
- insect bites
- minor skin irritations
Warnings
For external use only.
When using this product
- Do not use in or near the eyes
- Do not use in large quantities, particularily over raw surfaces or blistered areas
Stop use and ask a doctor if
Stop use and ask a doctor if
- allergic reaction occurs
- condition worsens or does not improve in 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 to 4 times a day |
Children under 2 years ask a doctor
Other information
- May be applied under occlusive dressing.
- Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.
Inactive ingredients
benzyl alcohol, carbomer, cholesterol, lecithin, polysorbate 80, propylene glycol, purified water, sodium hydroxide, titanium dioxide, tocopheryl acetate.
Package Label
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71351-018-01 | GM - Gram | 71351-018 | e2a0837c-54cf-42be-a0c4-5d4562e949ab | 1 | 2019-12-10 |
| 71351-018-03 | GM - Gram | 71351-018 | 31a085bf-149e-4bba-bbb6-aede898e5751 | 1 | 2019-12-10 |
Products#
Every source-derived product name is available through these pages.
- Lidocaine HCl
- HYDROGENATED SOYBEAN LECITHIN
- TITANIUM DIOXIDE
- CHOLESTEROL
- WATER
- PROPYLENE GLYCOL
- POLYSORBATE 80
- CARBOMER HOMOPOLYMER TYPE C
- BENZYL ALCOHOL
- SODIUM HYDROXIDE
- LIDOCAINE HYDROCHLORIDE
- LIDOCAINE
- LIDOCAINE HYDROCHLORIDE ANHYDROUS
- .ALPHA.-TOCOPHEROL ACETATE, DL-
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71351-018 | 71351-018-01, 71351-018-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYDROGENATED SOYBEAN LECITHIN | H1109Z9J4N | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| CHOLESTEROL | 97C5T2UQ7J | IACT |
| WATER | 059QF0KO0R | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| CARBOMER HOMOPOLYMER TYPE C | 4Q93RCW27E | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| LIDOCAINE HYDROCHLORIDE | V13007Z41A | ACTIR |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | WR1WPI7EW8 | 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 |
|---|---|---|---|---|---|---|
| d0eb2ff4-e906-2be5-e053-2a95a90af3d6 | 97b5a1f3-6d94-216c-e053-2a95a90aa189 | 2021-11-16 | Warnings | d0eb2ff4-e906-2be5-e053-2a95a90af3d6 97b5a1f3-6d94-216c-e053-2a95a90aa189 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.