PRAX- pramoxine hydrochloride lotion 
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® Lotion (Pramoxine HCl 1%)

Active Ingredient

pramoxine HCl 1% w/w

Purpose

local anesthetic

Use

for the temporary relief of discomfort and itch in the perianal area

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


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

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

PraxLotion8oz

PRAX 
pramoxine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0496-0748
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
PETROLATUM (UNII: 4T6H12BN9U)  
LANOLIN (UNII: 7EV65EAW6H)  
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
SORBIC ACID (UNII: X045WJ989B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0496-0748-03237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2012
2NDC:0496-0748-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2012
3NDC:0496-0748-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/01/2012
Labeler - Ferndale Laboratories, Inc. (005320536)
Establishment
NameAddressID/FEIBusiness Operations
Ferndale Laboratories, Inc.005320536manufacture(0496-0748)

Revised: 11/2019
Document Id: 97a2d217-11a5-fd4c-e053-2a95a90ab4de
Set id: 674f0d8b-3d50-42b1-8401-d2967bcdf5cf
Version: 2
Effective Time: 20191118
 
Ferndale Laboratories, Inc.