Active Ingredient(S)
Pramoxine hydrochloride 1% (w/w)
Honey Pot
FDA Label NDC 71505-022
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Disposable Hygiene Llc Dba Anthem for the product Honey Pot (NDC 71505-022). 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(s), purpose, use, warnings, otc - when using, otc - stop use, otc - keep out 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
Purpose
External analgesic
Use
For temporary relief of pain and itching associated with minor skin irritations.
Warnings
For external use only.
Otc - When Using
When using this product: avoid contact with eyes.
Otc - 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.
Otc - 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).
Otc - Questions
For questions and general information visit us at www.thehoneypot.co/contact
Package Label - Principal Display Panel
80 mL NDC: 71505-022-80
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