PRAX- pramoxine hydrochloride lotion

PRAX by

Drug Labeling and Warnings

PRAX by is a Otc medication manufactured, distributed, or labeled by Ferndale Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Shake well before use.
• When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
• Adults and children 12 years of age and older: apply to affected area up to 5 times daily.
• Children under 12 years of age: consult a doctor.

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

INGREDIENTS AND APPEARANCE

PRAX 
pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0496-0748
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0496-0748-03	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2012
2	NDC: 0496-0748-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2012
3	NDC: 0496-0748-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	04/01/2012

Labeler - Ferndale Laboratories, Inc. (005320536)

Establishment
Name	Address	ID/FEI	Business Operations
Ferndale Laboratories, Inc.		005320536	manufacture(0496-0748)