Prax Wipe

Dosage form: swab
Ingredients: PRAMOXINE HYDROCHLORIDE 10mg in 1g
Labeler: Ferndale Laboratories, Inc.
NDC Code: 0496-0749

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Prax Wipe

ACTIVE INGREDIENT

pramoxine HCl 1% w/w

PURPOSE

local anesthetic

USES
  • temporary relief of discomfort and itch in the perianal area
  • anogenital cleansing

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
  • redness, irritation, swelling, pain, bleeding, or other symptoms begin or increase

Keep out of reach of children.

If swallowed, seek medical attention or contact a Poison Control Center right away.

DIRECTIONS

When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently apply wipe to the affected area by patting and then discard.

adults and children 12 years and older - apply up to 5 times daily

children under 12 years - ask a doctor

INACTIVE INGREDIENTS

citric acid, glycerin, phenoxyethanol, potassium sorbate, purified water, and sodium citrate

PRINCIPAL DISPLAY PANEL

NDC 0496-0749-76

Contains 1 Single-Use Wipe

Prax® Wipe

(Pramoxine HCl 1%)
Emollient Formula

Pre-Moistened Anorectal Wipe
  • Non-Caine
  • Non-Steroid
  • Paraben-Free

Ferndale Laboratories, Inc.
Ferndale, MI 48220 U.S.A.
Toll free (888) 548-0900
www.ferndalelaboratories.com

Rev.: 05/09


PRAX WIPE 
pramoxine hydrochloride 1% swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0496-0749
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
GLYCERIN 
PHENOXYETHANOL 
POTASSIUM SORBATE 
WATER 
TRISODIUM CITRATE DIHYDRATE 
Packaging
#Item CodePackage Description
1NDC:0496-0749-6512 POUCH (POUCH) in 1 BOX
1NDC:0496-0749-766 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34608/01/2009
Labeler - Ferndale Laboratories, Inc. (005320536)
Establishment
NameAddressID/FEIOperations
Ferndale Laboratories, Inc.005320536manufacture

Revised: 08/2009
 
Ferndale Laboratories, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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