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First Degree Maximum Strength Burn

Medically reviewed on March 9, 2017

Dosage form: cream
Ingredients: Pramoxine Hydrochloride 10mg in 1g
Labeler: Welmedix LLC
NDC Code: 24330-130

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

First° Degree® Maximum Strength Burn Cream

Drug Facts

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

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

Distributed by:
Welmedix Consumer Healthcare
Princeton, NJ 08540

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)

FIRST DEGREE MAXIMUM STRENGTH BURN 
pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24330-130
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pramoxine Hydrochloride (Pramoxine) Pramoxine Hydrochloride10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:24330-130-021 TUBE in 1 BOX
121 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34803/09/2017
Labeler - Welmedix LLC (830387812)

 
Welmedix LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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