Prax® Lotion (pramoxine Hcl 1%)

Prax® Lotion (pramoxine Hcl 1%)
SPL v3
SPL
SPL Set ID 674f0d8b-3d50-42b1-8401-d2967bcdf5cf
Route
TOPICAL
Published
Effective Date 2012-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (10 mg)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-04-01

Description

pramoxine HCl 1% w/w

Purpose

local anesthetic


Medication Information

Purpose

local anesthetic

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



Warnings

For external use only.

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.



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

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



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

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



Purpose

local anesthetic

Warnings

For external use only.

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.



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

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



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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)