Label: ANTI-ITCH SOOTHING WIPES 1 PRAMOXINE HYDROCHLORIDE- pramoxine hydrochloride cloth

  • NDC Code(s): 82637-9363-1
  • Packager: The Honey Pot Company LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 19, 2023

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  • Drug Facts

  • Active Ingredient:

    Pramoxine Hydrochloride 1%

    Purpose:

    External Analgesic

  • Uses:

    For the temporary relief of pain and itching associated with minor skin irritations

  • Warnings:

    For external use only

    When using this product:

    avoid contact with eyes.

    Stop use and ask doctor if:

    • Condition worsens 
    • If symptoms persist for more than 7 days, or clear up and reoccur again withing a few days

    Keep out of reach of of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions:

    Adults and children 12 years of age and older: 

    Children under 12 years of age: Consult a doctor

    • Apply to affected area not more than 3 or 4 times daily.
  • Inactive Ingredients:

    Aloe Barbadensis Leaf Extract, *Aloe Barbadensis Leaf Juice, Althaea officinalis Root Extract, Avena Sativa (Oat) Kernel Extract, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocos Nucifera (Coconut) Fruit Extract, Cucumis Sativus (Cucumber) Fruit Extract, Disodium Cocoamphodiacetate, Ethylhexylglycerin, Euterpe Oleracea Fruit Extract, Fragrance, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Helianthus Annuus (Sunflower) Seed Oil, *Honey, Lactobacillus, Lactobacillus Ferment, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polyglyceryl-4 Caprate, Punica Granatum Fruit Extract, Rosa Centifolia Flower Water, Sodium Chloride, Tetrasodium Glutamate Diacetate Tocopheryl Acetate, *Vinegar (Apple Cider), Water *Organic Ingredients

  • Other Information:

    Store at a controlled room temperature 77°F (20-25°C).

  • Questions:

    For questions and general information visit us at www.thehoneypot.co/contact

  • Package Labeling:

    Outer Package

  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH SOOTHING WIPES 1 PRAMOXINE HYDROCHLORIDE 
    pramoxine hydrochloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82637-9363
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    OAT (UNII: Z6J799EAJK)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    COCONUT (UNII: 3RT3536DHY)  
    CUCUMBER (UNII: YY7C30VXJT)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ACAI (UNII: 46AM2VJ0AW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HONEY (UNII: Y9H1V576FH)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82637-9363-130 in 1 POUCH03/01/2022
    12.8 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/01/2022
    Labeler - The Honey Pot Company LLC (045600502)
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