FDA.reportPublic FDA data

Pramoxine HCl 1% Lotion

Manufacturer
Prime Labs LLC dba Quality CDMO
Effective date
2025-11-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-06-03 17:45:12

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.

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

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80587-18180587-181-01

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
NameUNIIKind
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
PETROLATUM4T6H12BN9UIACT
STEARYL ALCOHOL2KR89I4H1YIACT
MINERAL OILT5L8T28FGPIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
XANTHAN GUMTTV12P4NEEIACT
PEG-100 STEARATEYD01N1999RIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
43f72188-1990-273c-e063-6294a90a6a3243f71d36-20b4-6673-e063-6394a90af47c2025-11-19WarningsExact identifier
spl id: 43f72188-1990-273c-e063-6294a90a6a32
spl set id: 43f71d36-20b4-6673-e063-6394a90af47c

Reported adverse events (FAERS/openFDA)#

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