Label: PEVIDERM PRAMOXINE HYDROCHOLRIDE 1%- pramoxine hydrochloride lotion

  • NDC Code(s): 58980-913-80
  • Packager: Stratus Pharmaceuticals Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 7, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pramoxine Hydrochloride 1%

  • Purpose

    External Analgesic

  • Uses

    • for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac
  • Warnings

    for external use only

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breast-feeding, ask a health professional before use

    Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center immediately

  • Directions

    • to open, hold cap tightly and turn pump counter-clockwise

    Adults and children 2 years of age and older:

    • apply to affected area not more than 3 to 4 times daily

    Children under 2 years of age:

    • consult a doctor
  • Other information

    • Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]
  • Inactive ingredients

    Benzyl Alcohol, Carbomer 940, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Isopropyl Myristate, Petrolatum, PEG-8 Stearate, PEG-100 Stearate, Purified Water, Sodium Hydroxide, Stearic Acid.

  • Questions or comments?

    Call us at 1-800-442-7882

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    STRATUS
    PHARMACEUTICALS INC
    Miami, Florida 33186

  • PRINCIPAL DISPLAY PANEL - 222 mL Bottle Box

    NDC 58980-913-80

    Steroid-Free & Fragrance-Free

    PEVIDERM™
    PRAMOXINE HYDROCHLORIDE 1%

    ITCH RELIEF FOR SENSITIVE SKIN

    EXTERNAL
    ANALGESIC LOTION

    Moisturizes and gently relieves
    itch associated with:
    Eczema and
    Dry Sensitive Skin

    Net 7.5 fl oz (222 mL)

    PRINCIPAL DISPLAY PANEL - 222 mL Bottle Box
  • INGREDIENTS AND APPEARANCE
    PEVIDERM PRAMOXINE HYDROCHOLRIDE 1% 
    pramoxine hydrochloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-913
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pramoxine Hydrochloride (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) Pramoxine Hydrochloride1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glyceryl Stearate/PEG-100 Stearate (UNII: RD25J5V947)  
    PEG-8 Stearate (UNII: 2P9L47VI5E)  
    Calcium Chloride (UNII: M4I0D6VV5M)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Cetyl Palmitate (UNII: 5ZA2S6B08X)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    White Petrolatum (UNII: B6E5W8RQJ4)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58980-913-801 in 1 BOX11/01/2024
    1222 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01711/01/2024
    Labeler - Stratus Pharmaceuticals Inc (789001641)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tarmac Products Inc059890491MANUFACTURE(58980-913)
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