Label: ANTI ITCH SOOTHING 1 PRAMOXINE HYDROCHLORIDE- pramoxine hydrochloride spray

  • NDC Code(s): 82637-9370-1
  • 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 HCl 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 within a few days

    Keep out of reach of children.

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

  • Directions:

    Apply to affected not more than 3 or 4 times daily. Adults and children 12 years of age and older:

    Children under 12 years of age: Consult a doctor

  • Inactive Ingredients:

    Water, Polysorbate 20, Glycerin, Pentylene Glycol, Hamamelis virginiana (Witch Hazel) Water, Benzoic Acid, Fragrance, Honey, Vinegar, Aloe Barbadensis Leaf Juice, Sodium Hydroxide, Cucumis Sativus (Cucumber) Fruit Extract, Lavender (Lavandula Angutifolia) Extract, Calendula Officinalis (Calendula) Flower Extract, Cocos Nucifera (Coconut) Fruit Extract, Allium Sativum (Garlic) Extract, Olea Europaea (Olive) Leaf Extract, Potassium Sorbate, Sodium Benzoate, Citric Acid

  • 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 PackageInner Package

  • INGREDIENTS AND APPEARANCE
    ANTI ITCH SOOTHING 1 PRAMOXINE HYDROCHLORIDE 
    pramoxine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82637-9370
    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
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    HONEY (UNII: Y9H1V576FH)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CUCUMBER (UNII: YY7C30VXJT)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    COCONUT (UNII: 3RT3536DHY)  
    GARLIC (UNII: V1V998DC17)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82637-9370-11 in 1 CARTON03/01/2022
    180 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    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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