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NDC 00496-0748-15 PRAX 10 mg/mL Details

PRAX 10 mg/mL

PRAX is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Ferndale Laboratories, Inc.. The primary component is PRAMOXINE HYDROCHLORIDE.

Product Information

NDC	00496-0748
Product ID	0496-0748_97a2d217-11a5-fd4c-e053-2a95a90ab4de
Associated GPIs	90850065104110
GCN Sequence Number	007423
GCN Sequence Number Description	pramoxine HCl LOTION 1 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	30520
HICL Sequence Number	002977
HICL Sequence Number Description	PRAMOXINE HCL
Brand/Generic	Brand
Proprietary Name	PRAX
Proprietary Name Suffix	n/a
Non-Proprietary Name	pramoxine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/mL
Substance Name	PRAMOXINE HYDROCHLORIDE
Labeler Name	Ferndale Laboratories, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00496-0748-15 (00496074815)

Pricing Information	N/A
NDC Package Code	0496-0748-15
Billing NDC	00496074815
Package	15 mL in 1 BOTTLE (0496-0748-15)
Marketing Start Date	2012-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 674f0d8b-3d50-42b1-8401-d2967bcdf5cf Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	04/01/2012

Labeler - Ferndale Laboratories, Inc. (005320536)

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

Revised: 11/2019

Document Id: 97a2d217-11a5-fd4c-e053-2a95a90ab4de

Set id: 674f0d8b-3d50-42b1-8401-d2967bcdf5cf

Version: 2

Effective Time: 20191118