FDA.reportPublic FDA data

Prostaderm

Manufacturer
EZP Corporation | Jinzhou Zijing Pharmaceutical Co. | Jinzhou Zijing Pharmaceutical Co., Ltd.
Effective date
2015-02-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:41:51

Label at a glance#

ProductProstaderm
Active ingredientCAMPHOR (SYNTHETIC)
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                         Purpose

Camphor 3%...........................External analgesic

OTC - PURPOSE SECTION

Uses For the temporary relief of pain

OTC - WHEN USING SECTION

When using this product

  • Do not exceed recommended dosage
  • Do not use otherwise than as directed
  • Do not apply to wounds or damaged skin

OTC - ASK DOCTOR/PHARMACIST SECTION

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive irritation of the skin develops
  • redness is present
  • side effects occur. You may report side effects to FDA at
    1–800–FDA–1088.

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 this and all drugs out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away
Do not use otherwise than as directed

OTC - QUESTIONS SECTION

  • Questions?1-877-806-3569

DOSAGE & ADMINISTRATION SECTION

Directions

  • Clean and dry affected area
  • Cut open pouch and remove patch
  • Remove Protective film and apply directly to the navel vertically
  • Do not apply to area with excessive hair. Highly adhesive patch, may hurt skin upon removal
AdultsApply to affected area for 24-48 hours
Children under 18 years of ageAsk a doctor

WARNINGS SECTION

For external use only.

Do not use otherwise than as directed

INDICATIONS & USAGE SECTION

Uses For the temporary relief of pain.

INACTIVE INGREDIENT SECTION

Cistanche Deserticola stem, Syzygium aromaticum whole, Commiphora myrrha resin, Corydalis bungeana whole, Dictamnus dasycarps root bark, Foeniculum vulgare whole, Synthetic moschus resin, Polyvinyl alcohol, Glycerol, Laurocapram

Prostaderm PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Prostaderm PDPProstaderm PDP

Prostaderm Drug Facts

PATIENT MEDICATION INFORMATION SECTION

Prostaderm Drug FactsProstaderm Drug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1603829camphor 3 % Medicated PatchPSN1
1603829camphor 0.03 MG/MG Medicated PatchSCD1
1603829camphor 3 % Medicated PatchSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69446-100-012020-01-31C16284748780-19d75b9d0-5a2e-f424-e053-dadaa90a57ceProstaderm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69446-100-01Prostaderm1 in 1 PACKAGEPLASTER11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69446-100PROSTADERM (CAMPHOR) PLASTER [EZP CORPORATION]1Legacy NDC, 1 package rows20150228_b6fe33fa-8c06-4280-be21-b5319dab990a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET1
CISTANCHE DESERTICOLA STEMINACTIVE INGREDIENT45BEI4ZF641
COMMIPHORA MYRRHA WHOLEINACTIVE INGREDIENTUU81N77RI71
CORYDALIS BUNGEANA WHOLEINACTIVE INGREDIENT732H9A883V1
DICTAMNUS DASYCARPUS ROOT BARKINACTIVE INGREDIENTLA97176ILS1
FOENICULUM VULGARE WHOLEINACTIVE INGREDIENTJ1UK54JBGH1
GLYCEROL FORMALINACTIVE INGREDIENT3L7GR2604E1
LAUROCAPRAMINACTIVE INGREDIENT1F3X9DRV9X1
MOSCHUS MOSCHIFERUS MUSK SAC RESININACTIVE INGREDIENT8KFK4W7KP71
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J9901
SYZYGIUM AROMATICUM WHOLEINACTIVE INGREDIENTEY9MMA0P6Y1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69446-10069446-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
CISTANCHE DESERTICOLA STEM45BEI4ZF64IACT
SYZYGIUM AROMATICUM WHOLEEY9MMA0P6YIACT
COMMIPHORA MYRRHA WHOLEUU81N77RI7IACT
CORYDALIS BUNGEANA WHOLE732H9A883VIACT
DICTAMNUS DASYCARPUS ROOT BARKLA97176ILSIACT
FOENICULUM VULGARE WHOLEJ1UK54JBGHIACT
MOSCHUS MOSCHIFERUS MUSK SAC RESIN8KFK4W7KP7IACT
POLYVINYL ALCOHOL532B59J990IACT
GLYCEROL FORMAL3L7GR2604EIACT
LAUROCAPRAM1F3X9DRV9XIACT

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 · 17 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SYSTEM / TOPICAL420 mgExact identifier — unii candidate
17 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990AEROSOL, FOAM / VAGINAL0.5 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SOLUTION / OPHTHALMIC6 mgExact identifier — unii candidate
17 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, EXTENDED RELEASE / ORAL96 mgExact identifier — unii candidate
17 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, COATED / ORAL0.7 mgExact identifier — unii candidate
17 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SOLUTION/ DROPS / OPHTHALMIC1.4 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET / ORAL165 mgExact identifier — unii candidate
17 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
17 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990CAPSULE / ORAL1.67 mgExact identifier — unii candidate
17 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990IMPLANT / INTRAVITREAL0.12 mgExact identifier — unii candidate
17 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SUSPENSION / OPHTHALMIC1.4 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SOLUTION / TOPICAL1.4 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SUSPENSION / AURICULAR (OTIC)0.05 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SUSPENSION/ DROPS / OPHTHALMIC1.4 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SUSPENSION / ORAL5 mgExact identifier — unii candidate
17 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990CREAM / VAGINAL0.5 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
17 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a2d1609e-8274-4e19-855f-03a787a3888cb6fe33fa-8c06-4280-be21-b5319dab990a2015-02-24WarningsExact identifier
spl id: a2d1609e-8274-4e19-855f-03a787a3888c
spl set id: b6fe33fa-8c06-4280-be21-b5319dab990a

Reported adverse events (FAERS/openFDA)#

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