First Degree Maximum Strength Burn Cream
FDA Label NDC 24330-130

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Welmedix Llc for the product First Degree Maximum Strength Burn (NDC 24330-130). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, do not use, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
Welmedix Consumer Healthcare
Princeton, NJ 08540

Active Ingredient

Pramoxine HCL 1%

Purpose

External analgesic

Uses

For the temporary relief of pain and itching associated with:

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

Warnings

For external use only. Avoid contact with the eyes

Do Not Use

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

Stop Use And Ask A Doctor If

  • 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

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 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

  • store at 20-25°C (68-77°F)

Inactive Ingredients

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?

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Monday through Friday, 9am-5pm EST

Principal Display Panel - 21 G Tube Box

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)

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