FIRST AID & BURN CREAM
- Manufacturer
- HART Health
- Effective date
- 2024-02-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:08:45
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients (in each gram):
Benzalkonium Chloride 0.13%
Lidocaine HCl 0.5%
OTC - PURPOSE SECTION
Purpose:
Topical Antiseptic
Topical Anesthetic
INDICATIONS & USAGE SECTION
Uses: Temporary relief of pain and to help prevent infection in
- minor cuts
- scrapes
- burns
WARNINGS SECTION
Warnings: For external use only. See a doctor immediately for serious burns
OTC - DO NOT USE SECTION
Do not use:
- in or near the eyes
- over large portions of the body
- in large quantities particularly over raw surfaces or blistered areas
- longer than 7 days unless directed by a doctor
- more than 1 to 3 times daily
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- serious burns
- animal bites
- deep or puncture wounds
OTC - STOP USE SECTION
Stop use and ask a doctor if
- condition lasts for more than 7 days
- condition worsens
- symptoms clear up and occur again within a few days
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. 1-800-222-1222
DOSAGE & ADMINISTRATION SECTION
Directions: do not use more than directed
Adults and children 2 years of age and over:
- clean the affected area
- apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
- may be covered with a sterile bandage
Children under 2 years of age: ask a doctor
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Aloe Vera, Cetyl Alcohol, Diazolidinyl Urea, Edetate Disodium, Glycerin, Clyceryl Monostearate, Methylparaben, Mineral Oil, Polyethylene Glycol, Propylene Glycol, Propylparaben, Purified Water, Stearic Acid, Trolamine
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1012100 | benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream | PSN | 4 |
| 1012100 | benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream | SCD | 4 |
| 1012100 | benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream | SY | 4 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50332-0037 | FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE) CREAM [HART HEALTH] | 4 | Current NDC, Legacy NDC | 20240217_f5746bba-9d7f-4691-b466-14985473bf14.zip |
Products#
Every source-derived product name is available through these pages.
- First Aid and Burn
- benzalkonium chloride, lidocaine
- BENZALKONIUM CHLORIDE
- BENZALKONIUM
- LIDOCAINE
- ALOE VERA LEAF
- ALCOHOL
- METHYLPARABEN
- MINERAL OIL
- PARAFFIN
- PROPYLPARABEN
- WATER
- PETROLATUM
- WHITE WAX
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50332-0037 | 50332-0037-1, 50332-0037-6, 50332-0037-2, 50332-0037-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | ACTIB |
| LIDOCAINE | 98PI200987 | ACTIB |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PARAFFIN | I9O0E3H2ZE | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| WHITE WAX | 7G1J5DA97F | 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 |
|---|---|---|---|---|---|---|
| First Aid and Burn | BENZALKONIUM CHLORIDE, LIDOCAINE | HART Health | f5746bba-9d7f-4691-b466-14985473bf14 | 2024-02-16 | Warnings | 50332-0037-4 50332-0037-2 50332-0037-6 50332-0037-1 50332-0037 50332003701 50332003706 50332003702 50332003704 94349edb-f001-44cb-82af-6b44cb352d84 f5746bba-9d7f-4691-b466-14985473bf14 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
