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PRAX

Ferndale Laboratories, Inc.

Prax® Lotion (Pramoxine HCl 1%)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

PRAX

PRAX

pramoxine hydrochloride LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0496-0748
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
pramoxine hydrochloride PRAMOXINE 10 mg

Inactive Ingredients

Ingredient Name Strength
CETYL ALCOHOL
DIISOPROPYL ADIPATE
DIMETHICONE
GLYCERIN
petrolatum
LANOLIN
HYDROGENATED COCONUT OIL
SORBITAN SESQUIOLEATE
stearyl alcohol
Mineral Oil
POLYOXYL 40 STEARATE
POTASSIUM SORBATE
povidone
water
sorbic acid
STEARIC ACID
TROLAMINE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0496-0748-03 237 in 1 BOTTLE
2 NDC:0496-0748-04 118 in 1 BOTTLE
3 NDC:0496-0748-15 15 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2012-04-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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