FDA.reportPublic FDA data

Peviderm Pramoxine Hydrocholride 1%

Manufacturer
Stratus Pharmaceuticals Inc | Tarmac Products Inc
Effective date
2024-11-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:35:38

Label at a glance#

ProductPeviderm Pramoxine Hydrocholride 1%
Active ingredientPramoxine Hydrochloride
Label structure11 sections

Indications and uses

for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac

Dosage and administration

to open, hold cap tightly and turn pump counter-clockwise Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: consult a doctor

Storage and handling

Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine Hydrochloride 1%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac

Warnings

WARNINGS SECTION

for external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • to open, hold cap tightly and turn pump counter-clockwise

Adults and children 2 years of age and older:

  • apply to affected area not more than 3 to 4 times daily

Children under 2 years of age:

  • consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Carbomer 940, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Isopropyl Myristate, Petrolatum, PEG-8 Stearate, PEG-100 Stearate, Purified Water, Sodium Hydroxide, Stearic Acid.

Questions or comments?

OTC - QUESTIONS SECTION

Call us at 1-800-442-7882

SPL UNCLASSIFIED SECTION

Distributed by:
STRATUS
PHARMACEUTICALS INC
Miami, Florida 33186

PRINCIPAL DISPLAY PANEL - 222 mL Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58980-913-80

Steroid-Free & Fragrance-Free

PEVIDERM™
PRAMOXINE HYDROCHLORIDE 1%

ITCH RELIEF FOR SENSITIVE SKIN

EXTERNAL
ANALGESIC LOTION

Moisturizes and gently relieves
itch associated with:
Eczema and
Dry Sensitive Skin

Net 7.5 fl oz (222 mL)

PRINCIPAL DISPLAY PANEL - 222 mL Bottle Box
PRINCIPAL DISPLAY PANEL - 222 mL Bottle Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58980-913-80Peviderm Pramoxine Hydrocholride 1%222 mL in 1 BOTTLELOTION2222
58980-913-80Peviderm Pramoxine Hydrocholride 1%1 in 1 BOXLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-913PEVIDERM PRAMOXINE HYDROCHOLRIDE 1% (PRAMOXINE HYDROCHLORIDE) LOTION [STRATUS PHARMACEUTICALS INC]2Current NDC, 2 package rows20241109_680b40fa-1922-443a-a4b0-7c3f6a2b847d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-913-80ML - Milliliter58980-9137d00e397-db14-47f8-a67d-cbb7e210a15812024-11-05

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
58980-91358980-913-80

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
Pramoxine Hydrochloride88AYB867L5ACTIB
Water059QF0KO0RIACT
Glyceryl Stearate/PEG-100 StearateRD25J5V947IACT
PEG-8 Stearate2P9L47VI5EIACT
Calcium ChlorideM4I0D6VV5MIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
Cetyl Palmitate5ZA2S6B08XIACT
Isopropyl Myristate0RE8K4LNJSIACT
White PetrolatumB6E5W8RQJ4IACT
Stearic Acid4ELV7Z65APIACT
Benzyl AlcoholLKG8494WBHIACT
Sodium Hydroxide55X04QC32IIACT

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
Peviderm Pramoxine Hydrocholride 1%PRAMOXINE HYDROCHLORIDEStratus Pharmaceuticals Inc680b40fa-1922-443a-a4b0-7c3f6a2b847d2024-11-07WarningsExact identifier
ndc (package): 58980-913-80
ndc (product): 58980-913
ndc11 (package): 58980091380
spl id: 119ef16e-c873-41df-9e98-4ccade286a85
spl set id: 680b40fa-1922-443a-a4b0-7c3f6a2b847d

Reported adverse events (FAERS/openFDA)#

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