Active Ingredient
pramoxine HCl 1% w/w
Prax Lotion
FDA Label NDC 50268-682
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Avpak for the product Prax (NDC 50268-682). 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, use, warnings, do not, stop use and ask a doctor if, 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
local anesthetic
Use
for the temporary relief of discomfort and itch in the perianal area
Warnings
For external use only.
Do Not
- exceed the recommended daily dosage unless directed by a doctor
- put this product into the rectum by using fingers or any mechanical device or applicator
Stop Use And Ask A Doctor If
- condition worsens
- symptoms do not improve within 7 days
- allergic reactions develop to ingredients in this product
- symptom being treated does not subside or if redness, irritation, swelling, pain, bleeding, or other symptoms develop or increase
Keep Out Of Reach Of Children.
If swallowed, seek medical attention or contact a Poison Control Center right away.
Directions
- Shake well before use.
- When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
- Adults and children 12 years of age and older: apply to affected area up to 5 times daily.
- Children under 12 years of age: consult a doctor.
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Glycerin, Glyceryl Stearate SE, Mineral Oil, PEG-100 Stearate, Phenoxyethanol, Purified Water, Stearyl Alcohol, White Petrolatum, Xanthan Gum
Package Label
Questions or comments call 1-855-361-3993.
Manufactured for:
AvKARE
Pulaski, TN 38478
www.avkare.com
AV 01/2022
1 (682 15)
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