FDA.reportPublic FDA data

First° Degree ® Maximum Strength Burn Cream

Manufacturer
Welmedix LLC
Effective date
2017-03-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:26

Label at a glance#

ProductFirst Degree Maximum Strength Burn
Active ingredientPramoxine Hydrochloride
Label structure11 sections

Indications and uses

For the temporary relief of pain and itching associated with: minor burns insect bites sunburns minor cuts scrapes minor skin irritations

Dosage and administration

adults and children 2 years of age and older: clean the affected area apply to affected area not more than 3 to 4 times daily may be covered with a sterile bandage children under 2 years of age: ask a doctor

Storage and handling

store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCL 1%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with:

  • minor burns
  • insect bites
  • sunburns
  • minor cuts
  • scrapes
  • minor skin irritations

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes

Do not use

OTC - DO NOT USE SECTION

  • if you are allergic to any of the ingredients
  • over large areas of the body

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • rash or other allergic reaction develops

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older:
    • clean the affected area
    • apply to affected area not more than 3 to 4 times daily
    • may be covered with a sterile bandage
  • children under 2 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

butyrospermum parkii (shea butter), C18-22 hydroxyalkyl hydroxypropyl guar, calendula officinalis extract, cantharis vesicatoria extract, echinacea angustifolia extract, ethyl alcohol, hydrogenated polydecene, isopropyl myristate, lanolin, lanolin alcohol, petrolatum, phenoxyethanol, water, sodium hydroxide, sodium polyacryloyldimethyl taurate, trideceth-10

Questions or Comments?

OTC - QUESTIONS SECTION

1-888-565-2876
Monday through Friday, 9am-5pm EST

SPL UNCLASSIFIED SECTION

Distributed by:
Welmedix Consumer Healthcare
Princeton, NJ 08540

PRINCIPAL DISPLAY PANEL - 21 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW &
IMPROVED!

First°Degree®

MAXIMUM STRENGTH
BURN CREAM
PRAMOXINE HCL 1% PAIN RELIEVING CREAM

FAST RELIEF FOR
PAIN + ITCH

  • GREAT FOR
    MINOR
    BURNS
    BUG
    BITES
  • HELPS REDUCE THE APPEARANCE OF SCARS
  • ENRICHED WITH NOURISHING BOTANICALS

1 Tube
Net Wt 3/4 oz (21 g)

Principal Display Panel - 21 g Tube Box
Principal Display Panel - 21 g Tube Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052684pramoxine HCl 1 % Topical CreamPSN1
1052684pramoxine hydrochloride 10 MG/ML Topical CreamSCD1
1052684pramoxine hydrochloride 1 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24330-130-02First Degree Maximum Strength Burn1 in 1 BOXCREAM11
24330-130-02First Degree Maximum Strength Burn21 g in 1 TUBECREAM211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24330-130FIRST DEGREE MAXIMUM STRENGTH BURN (PRAMOXINE HYDROCHLORIDE) CREAM [WELMEDIX LLC]1Current NDC, Legacy NDC, 2 package rows20170329_1afa337e-f411-42df-b2f5-5f72c9b52ffa.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24330-13024330-130-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
Pramoxine Hydrochloride88AYB867L5ACTIB
SHEA BUTTERK49155WL9YIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQIACT
LYTTA VESICATORIA3Q034RO3BTIACT
GUAR GUME89I1637KEIACT
ECHINACEA ANGUSTIFOLIAVB06AV5US8IACT
ALCOHOL3K9958V90MIACT
HYDROGENATED POLYDECENE (550 MW)U333RI6EB7IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LANOLIN7EV65EAW6HIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
PETROLATUM4T6H12BN9UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM TAURATEY7LJA74T0NIACT
TRIDECETH-10G624N6MSBAIACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Degree Maximum Strength BurnPRAMOXINE HYDROCHLORIDEWelmedix LLC1afa337e-f411-42df-b2f5-5f72c9b52ffa2017-03-09WarningsExact identifier
ndc (package): 24330-130-02
ndc (product): 24330-130
ndc11 (package): 24330013002
spl id: cbfe71fd-2d5c-4c98-8caf-68fe49e54b6f
spl set id: 1afa337e-f411-42df-b2f5-5f72c9b52ffa

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.