FDA Label for Prax
View Indications, Usage & Precautions
Prax Product Label
The following document was submitted to the FDA by the labeler of this product Ferndale Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
pramoxine HCl 1% w/w
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
cetyl alcohol, di-isopropyl adipate, dimethicone, glycerin, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), mineral oil, polyoxyl 40 stearate, potassium sorbate, povidone, purified water, sorbic acid, stearic acid, and trolamine
Package Label
Manufactured for
Ferndale Healthcare® Inc.
By Ferndale Laboratories, Inc.
Ferndale, MI 48220 U.S.A.
Toll Free (888) 548-0900
www.ferndalehealthcare.com
8 fl oz (237 mL) NDC 0496-0748-03
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