Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)
Ferndale Laboratories, Inc.
TOPICAL
OTC DRUG
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
OTC monograph final
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 Lesen Sie das vollständige Dokument