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  5. Label Information: First Degree Maximum Strength Burn

FDA Label for First Degree Maximum Strength Burn

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PRINCIPAL DISPLAY PANEL - 21 G TUBE BOX

First Degree Maximum Strength Burn Product Label

The following document was submitted to the FDA by the labeler of this product Welmedix Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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?



1-888-565-2876
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

* Please review the disclaimer below.