Drugplain

PRAX 10 mg/mL

pramoxine hydrochloride · LOTION · Ferndale Laboratories, Inc.

No Recall History
Plain English

PRAX is a lotion containing pramoxine hydrochloride at 10 mg/mL, taken topical. Manufactured by Ferndale Laboratories, Inc..

Key Facts

Brand Name
PRAX
Generic Name
pramoxine hydrochloride
NDC Code (Product)
0496-0748
Manufacturer
Ferndale Laboratories, Inc.
Strength
10 mg/mL
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M015
Marketing Start
04/01/2012

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

chest discomfort14 reports
cough14 reports
dyspnoea14 reports
sinusitis14 reports
asthma13 reports
candida infection13 reports
deep vein thrombosis13 reports
dyspnoea exertional13 reports
eczema13 reports
oedema peripheral13 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use for the temporary relief of discomfort and itch in the perianal area

Dosage & Administration

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.

Warnings

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.

Frequently Asked Questions

What is PRAX used for?

PRAX contains pramoxine hydrochloride. It is a lotion taken topical. Consult your doctor for specific uses.

Is PRAX a controlled substance?

PRAX is not classified as a controlled substance by the DEA.

What is the generic name for PRAX?

The generic name for PRAX is pramoxine hydrochloride. There are 11 other brand versions of pramoxine hydrochloride.

What is the NDC code for PRAX 10 mg/mL?

The NDC (National Drug Code) for PRAX 10 mg/mL is 0496-0748, listed by Ferndale Laboratories, Inc..