Prax® Lotion (Pramoxine HCl 1%)

Manufacturer: Ferndale Laboratories, Inc.
Effective date: 2024-12-17
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 00:44:13

Label at a glance#

ProductPRAX

Active ingredientPRAMOXINE HYDROCHLORIDE

Label structure7 sections

Dosage and administration

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.

Contacts and useful links#

PhoneLabel contact(888) 548-0900

Websitewww.ferndalehealthcare.com

www.ferndalehealthcare.com

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

pramoxine HCl 1% w/w

Purpose

OTC - PURPOSE SECTION

local anesthetic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Do not

OTC - DO NOT USE SECTION

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

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, seek medical attention or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1246075	pramoxine HCl 1 % Topical Lotion	PSN	3
1246076	Prax 1 % Topical Lotion	PSN	3
1246076	pramoxine hydrochloride 10 MG/ML Topical Lotion [Prax]	SBD	3
1246075	pramoxine hydrochloride 10 MG/ML Topical Lotion	SCD	3
1246075	pramoxine hydrochloride 1 % Topical Lotion	SY	3
1246076	Prax 1 % Topical Lotion	SY	3
1246076	Prax 10 MG/ML Topical Lotion	SY	3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0496-0748-03	PRAX	237 mL in 1 BOTTLE	LOTION	237	3
0496-0748-04	PRAX	118 mL in 1 BOTTLE	LOTION	118	3
0496-0748-15	PRAX	15 mL in 1 BOTTLE	LOTION	15	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0496-0748	PRAX (PRAMOXINE HYDROCHLORIDE) LOTION [FERNDALE LABORATORIES, INC.]	3	Current NDC, Legacy NDC, 3 package rows	20241219_674f0d8b-3d50-42b1-8401-d2967bcdf5cf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0496-0748-03	ML - Milliliter	0496-0748	b6504dad-0912-4d55-9453-e5d6c6a530c0	1	2013-07-02
0496-0748-04	ML - Milliliter	0496-0748	b54a913e-a7ae-4fa8-ac21-94664fed7c1b	1	2013-07-02
0496-0748-15	ML - Milliliter	0496-0748	04165e3a-56fa-4666-879e-9ba452700668	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	1
PRAMOXINE	ACTIVE MOIETY	068X84E056	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	1
DIISOPROPYL ADIPATE	INACTIVE INGREDIENT	P7E6YFV72X	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
HYDROGENATED COCONUT OIL	INACTIVE INGREDIENT	JY81OXM1OM	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	1
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

PRAX
pramoxine hydrochloride
CETYL ALCOHOL
DIISOPROPYL ADIPATE
DIMETHICONE
GLYCERIN
PETROLATUM
LANOLIN
HYDROGENATED COCONUT OIL
SORBITAN SESQUIOLEATE
STEARYL ALCOHOL
MINERAL OIL
POLYOXYL 40 STEARATE
POTASSIUM SORBATE
POVIDONE
WATER
SORBIC ACID
STEARIC ACID
TROLAMINE
PRAMOXINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0496-0748	0496-0748-03, 0496-0748-04, 0496-0748-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETYL ALCOHOL	936JST6JCN	IACT
DIISOPROPYL ADIPATE	P7E6YFV72X	IACT
DIMETHICONE	92RU3N3Y1O	IACT
GLYCERIN	PDC6A3C0OX	IACT
PETROLATUM	4T6H12BN9U	IACT
LANOLIN	7EV65EAW6H	IACT
HYDROGENATED COCONUT OIL	JY81OXM1OM	IACT
SORBITAN SESQUIOLEATE	0W8RRI5W5A	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
MINERAL OIL	T5L8T28FGP	IACT
POLYOXYL 40 STEARATE	13A4J4NH9I	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
POVIDONE	FZ989GH94E	IACT
WATER	059QF0KO0R	IACT
SORBIC ACID	X045WJ989B	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TROLAMINE	9O3K93S3TK	IACT
PRAMOXINE HYDROCHLORIDE	88AYB867L5	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 60 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
DIISOPROPYL ADIPATE	DIISOPROPYL ADIPATE	P7E6YFV72X	LOTION / TOPICAL		250 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	LOTION / TOPICAL		360 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
DIISOPROPYL ADIPATE	DIISOPROPYL ADIPATE	P7E6YFV72X	LOTION / TOPICAL		250 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROGENATED COCONUT OIL	HYDROGENATED COCONUT OIL	JY81OXM1OM	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SYSTEM / TOPICAL		41 mg	Exact identifier — unii+route 4 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	LOTION / TOPICAL		4 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	LOTION / TOPICAL		360 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	LOTION / TOPICAL		360 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SYSTEM / TOPICAL		41 mg	Exact identifier — unii+route 4 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	LOTION / TOPICAL		360 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	LOTION / TOPICAL		4 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SYSTEM / TOPICAL		41 mg	Exact identifier — unii+route 4 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	LOTION / TOPICAL		4 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
DIISOPROPYL ADIPATE	DIISOPROPYL ADIPATE	P7E6YFV72X	LOTION / TOPICAL		250 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SORBITAN SESQUIOLEATE	SORBITAN SESQUIOLEATE	0W8RRI5W5A	OINTMENT / TOPICAL		75 mg	Exact identifier — unii+route 4 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SYSTEM / TOPICAL		41 mg	Exact identifier — unii+route 4 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROGENATED COCONUT OIL	HYDROGENATED COCONUT OIL	JY81OXM1OM	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
SORBITAN SESQUIOLEATE	SORBITAN SESQUIOLEATE	0W8RRI5W5A	OINTMENT / TOPICAL		75 mg	Exact identifier — unii+route 4 equally ranked IID candidates
SORBITAN SESQUIOLEATE	SORBITAN SESQUIOLEATE	0W8RRI5W5A	OINTMENT / TOPICAL		75 mg	Exact identifier — unii+route 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SORBITAN SESQUIOLEATE	SORBITAN SESQUIOLEATE	0W8RRI5W5A	OINTMENT / TOPICAL		75 mg	Exact identifier — unii+route 4 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	LOTION / TOPICAL		4 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROGENATED COCONUT OIL	HYDROGENATED COCONUT OIL	JY81OXM1OM	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
DIISOPROPYL ADIPATE	DIISOPROPYL ADIPATE	P7E6YFV72X	LOTION / TOPICAL		250 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROGENATED COCONUT OIL	HYDROGENATED COCONUT OIL	JY81OXM1OM	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRAX	PRAMOXINE HYDROCHLORIDE	Ferndale Laboratories, Inc.	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	2024-12-17	Warnings	Exact identifier ndc (package): 0496-0748-15 ndc (package): 0496-0748-03 ndc (package): 0496-0748-04 ndc (product): 0496-0748 ndc11 (package): 00496074815 ndc11 (package): 00496074803 ndc11 (package): 00496074804 spl id: 297a2f2f-8355-6e34-e063-6394a90add60 spl set id: 674f0d8b-3d50-42b1-8401-d2967bcdf5cf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.