Label: FIRST DEGREE MAXIMUM STRENGTH BURN- pramoxine hydrochloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated March 9, 2017

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  • SPL UNCLASSIFIED SECTION

    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

  • SPL UNCLASSIFIED SECTION

    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)

    Principal Display Panel - 21 g Tube Box
  • INGREDIENTS AND APPEARANCE
    FIRST DEGREE MAXIMUM STRENGTH BURN 
    pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24330-130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)  
    LYTTA VESICATORIA (UNII: 3Q034RO3BT)  
    GUAR GUM (UNII: E89I1637KE)  
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
    ALCOHOL (UNII: 3K9958V90M)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM TAURATE (UNII: Y7LJA74T0N)  
    TRIDECETH-10 (UNII: G624N6MSBA)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24330-130-021 in 1 BOX03/09/2017
    121 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34803/09/2017
    Labeler - Welmedix LLC (830387812)
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