Dermagesic

Manufacturer
Llorens Pharmaceutical International Division
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:30:33

Label at a glance#

ProductDermagesic
Active ingredientPRAMOXINE HYDROCHLORIDE, ZINC OXIDE, FERRIC OXIDE RED
Label structure9 sections

Indications and uses

for temporary reilef of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor irritation dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Dosage and administration

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 ask a doctor Do not use more often than directed

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCl 1%

Zinc Oxide 0.4%

Calamine 0.4%

Purpose

OTC - PURPOSE SECTION

Anestheric/Analgesic

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • for temporary reilef of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor irritation
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes

  • Not for Pediatric use
  • Hypersensitivity to "caine" anesthetics

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth.

Ask a doctor before use

  • on chicken pox
  • on measles

Stop use and ask a doctor if condition worsens or does not improve within 7 days

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

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions 

DOSAGE & ADMINISTRATION SECTION

  • 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 ask a doctor
  • Do not use more often than directed

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Badbadensis Leaf juice (Aloe Vera), Avena Sativa (Oat) Kernal colloidal, cetyl stearyl alcohol, ceteareth-6, ceteareth-25, diazolidinyl urea, fragrance, menthol, methyl paraben, paraffinum liquidum, propylene glycol, propyl paraben, purified water, stearyl alcohol

Questions or Comments

OTC - QUESTIONS SECTION

1-866-595-5598

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dermagesic CreamDermagesic Cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1798481pramoxine HCl 1 % / zinc oxide 0.4 % / calamine 0.4 % Topical CreamPSN9
1798481calamine 4 MG/ML / pramoxine hydrochloride 10 MG/ML / zinc oxide 4 MG/ML Topical CreamSCD9
1798481calamine 0.4 % / pramoxine HCl 1 % / zinc oxide 0.4 % Topical CreamSY9
1798481Calamine 4 MG/ML / Pramoxine hydrochloride 10 MG/ML / ZNO 4 MG/ML Topical CreamSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54859-202-042020-12-23C16284748780-19d75b9cf-e9ea-f424-e053-dadaa90a57ceDermagesic 202
54859-202-042020-01-31C16284748780-19d75b9cf-e9ea-f424-e053-dadaa90a57ceDermagesic 202

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-202-04Dermagesic113 g in 1 JARCREAM1139

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54859-20254859-202-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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
DermagesicPRAMOXINE HCL, ZINC OXIDE, CALAMINELlorens Pharmaceutical International Divisionbbff6b53-29da-45c1-8ccd-3e9df7f250e02025-12-31WarningsExact identifier
ndc (package): 54859-202-04
ndc (product): 54859-202
ndc11 (package): 54859020204
spl id: 47467902-6ca7-2b20-e063-6394a90aeff1
spl set id: bbff6b53-29da-45c1-8ccd-3e9df7f250e0

Reported adverse events (FAERS/openFDA)#

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