PRAX- pramoxine hydrochloride 1% cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)

Available from:

Ferndale Laboratories, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

local anesthetic - for the temporary relief of itching and discomfort in the perianal area - anorectal cleansing - 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

Authorization status:

OTC monograph final

Summary of Product characteristics

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._
----------
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
Pouch Back
PRAX
pramoxine hydrochloride 1% cloth
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:0 49 6 -0 741
ROUTE OF ADMINISTRATION
TOPICAL
Ferndale Laboratories, Inc.
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PRAMO XINE HYDRO CHLO RIDE (UNII: 8 8 AYB8 6 7L5) (PRAMOXINE -
UNII:0 6 8 X8 4E0 56 )
PRAMOXINE
HYDROCHLORIDE
10 mg
in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6 A3C0 OX)
PHENO XYETHANO L (UNII: HIE49 2ZZ3T)
WATER (UNII: 0 59 QF0 KO0 R)
SO DIUM CITRA