Pramoxine HCl 1% Lotion

Manufacturer: AvPAK
Effective date: 2026-01-09
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: monthly-update
Hydrated at: 2026-06-03 17:51:39

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 contact1-855-361-3993

Websitewww.avkare.com

www.avkare.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

Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Glycerin, Glyceryl Stearate SE, Mineral Oil, PEG-100 Stearate, Phenoxyethanol, Purified Water, Stearyl Alcohol, White Petrolatum, Xanthan Gum

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Questions or comments call 1-855-361-3993.

Manufactured for:

AvKARE

Pulaski, TN 38478

www.avkare.com

AV 01/2022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1246075	pramoxine HCl 1 % Topical Lotion	PSN	4
1246075	pramoxine hydrochloride 10 MG/ML Topical Lotion	SCD	4
1246075	pramoxine hydrochloride 1 % Topical Lotion	SY	4

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	Strength	SPL version
50268-682-15	PRAX	237 mL in 1 BOTTLE	LOTION	237		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-682-15	ML - Milliliter	50268-682	2eb1467f-6e41-4a05-bda9-dc00f6d1590f	1	2022-05-04

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

PRAX
pramoxine hydrochloride
CETYL ALCOHOL
GLYCERIN
PETROLATUM
STEARYL ALCOHOL
MINERAL OIL
WATER
PRAMOXINE
PHENOXYETHANOL
GLYCERYL STEARATE SE
XANTHAN GUM
PEG-100 STEARATE
ALOE VERA LEAF

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50268-682	50268-682-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETYL ALCOHOL	936JST6JCN	IACT
GLYCERIN	PDC6A3C0OX	IACT
PETROLATUM	4T6H12BN9U	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
MINERAL OIL	T5L8T28FGP	IACT
WATER	059QF0KO0R	IACT
PRAMOXINE HYDROCHLORIDE	88AYB867L5	ACTIB
PHENOXYETHANOL	HIE492ZZ3T	IACT
GLYCERYL STEARATE SE	FCZ5MH785I	IACT
XANTHAN GUM	TTV12P4NEE	IACT
PEG-100 STEARATE	YD01N1999R	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
3	2024-03-06	full-release	2026-06-01 00:09:34

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	AvPAK	dc646399-91ba-5cc1-e053-2a95a90a4f9c	2026-01-09	Warnings	Exact identifier ndc (package): 50268-682-15 ndc (product): 50268-682 ndc11 (package): 50268068215 spl id: 47fbf804-a248-931b-e063-6294a90abc2b spl set id: dc646399-91ba-5cc1-e053-2a95a90a4f9c

Reported adverse events (FAERS/openFDA)#

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