Anti Itch Soothing 1 Pramoxine Hydrochloride Spray
FDA Label NDC 82637-9370

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 1 Pramoxine Hydrochloride (NDC 82637-9370). 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 drug facts, active ingredient:, purpose:, uses:, warnings:, when using this product:, stop use and ask doctor if:, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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:

Adults and children 12 years of age and older: Apply to affected 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 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

* Please review the disclaimer below.