Prax Wipe

Drug Labeling and Warnings

Drug Details [pdf]

PRAX- pramoxine hydrochloride 1% cloth 
Ferndale Laboratories, Inc.

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.

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Prax Wipe

ACTIVE INGREDIENT

pramoxine HCl 1% w/w

PURPOSE

local anesthetic

USES

  • for the temporary relief of itching and discomfort in the perianal area
  • anorectal 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
  • 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

  • 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, purified water, and sodium citrate

Package Label

NDC: 0496-0741-76

Pouch Front

frontpouch

Pouch Back

backpouch

PRAX 
pramoxine hydrochloride 1% cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0496-0741
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0496-0741-6512 in 1 CARTON02/01/201602/28/2018
1NDC: 0496-0741-766 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34602/01/201602/28/2018
Labeler - Ferndale Laboratories, Inc. (005320536)
Registrant - Ferndale Laboratories, Inc. (005320536)
Establishment
NameAddressID/FEIBusiness Operations
Ferndale Laboratories, Inc.005320536manufacture(0496-0741)

Revised: 10/2019
Document Id: 946ac560-b78b-2aa2-e053-2995a90a69ac
Set id: 2b08cf96-0ddf-5179-e054-00144ff88e88
Version: 2
Effective Time: 20191008