First° Degree ® Maximum Strength Burn Cream

Label at a glance#

Contacts and useful links#

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

FIRST DEGREE MAXIMUM STRENGTH BURN (PRAMOXINE HYDROCHLORIDE) CREAM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Products#

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

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

• First Degree Maximum Strength Burn
• Pramoxine Hydrochloride
• PRAMOXINE
• SHEA BUTTER
• CALENDULA OFFICINALIS FLOWERING TOP
• LYTTA VESICATORIA
• GUAR GUM
• ECHINACEA ANGUSTIFOLIA
• ALCOHOL
• HYDROGENATED POLYDECENE (550 MW)
• ISOPROPYL MYRISTATE
• LANOLIN
• LANOLIN ALCOHOLS
• PETROLATUM
• PHENOXYETHANOL
• WATER
• SODIUM HYDROXIDE
• SODIUM TAURATE
• TRIDECETH-10

NDC Codes#

Ingredients#

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

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

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.

Reported adverse events (FAERS/openFDA)#

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