prax® lotion (pramoxine hcl 1%)
674f0d8b-3d50-42b1-8401-d2967bcdf5cf
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
local anesthetic
Description
pramoxine HCl 1% w/w
Medication Information
Warnings
For external use only.
Purpose
local anesthetic
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
Description
pramoxine HCl 1% w/w
Use
for the temporary relief of discomfort and itch in the perianal area
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
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
Active Ingredient
pramoxine HCl 1% w/w
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.
Structured Label Content
Warnings
For external use only.
Purpose
local anesthetic
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
Use
for the temporary relief of discomfort and itch in the perianal area
Do Not (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
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
Active Ingredient
pramoxine HCl 1% w/w
Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)
If swallowed, seek medical attention or contact a Poison Control Center right away.
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Source: dailymed · Ingested: 2026-02-15T12:04:51.974175 · Updated: 2026-03-14T23:05:57.575147