Label: HONEY POT- anti-itch soothing liquid

  • 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 February 15, 2022

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  • Active Ingredient(s)

    Pramoxine hydrochloride 1% (w/w)

  • Purpose

    External analgesic

  • Use

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

  • Warnings

    For external use only.

  • WHEN USING

    When using this product: avoid contact with eyes.

  • STOP USE

    Stop use and ask a 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

    Keep out 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: Apply to the affected area not more than 3 or 4 times daily. 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 Angustifolia) 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 of 77°F (20-25°C).

  • QUESTIONS

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

  • Package Label - Principal Display Panel

    80 mL NDC: 71505-022-80

    80 mL NDC: 71505-022-80

  • INGREDIENTS AND APPEARANCE
    HONEY POT 
    anti-itch soothing liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71505-022
    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
    ACETIC ACID (UNII: Q40Q9N063P)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GARLIC OIL (UNII: 4WG8U28833)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    HONEY (UNII: Y9H1V576FH)  
    CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71505-022-8080 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/15/2022
    Labeler - Disposable Hygiene LLC dba Anthem (079848737)
    Establishment
    NameAddressID/FEIBusiness Operations
    Disposable Hygiene LLC dba Anthem079848737manufacture(71505-022)
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