Anti-itch Soothing Wipes 1 Pramoxine Hydrochloride Cloth
FDA Label NDC 82637-9363

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Honey Pot Company Llc for the product Anti-itch Soothing Wipes 1 Pramoxine Hydrochloride (NDC 82637-9363). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient:, purpose:, uses:, warnings:, when using this product:, stop use and ask doctor if:, keep out of reach of of reach of children., directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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: 

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

    • Children under 12 years of age: Consult a doctor

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

* Please review the disclaimer below.