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  5. Label Information: Prostaderm

FDA Label for Prostaderm

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. OTC - WHEN USING
    4. OTC - ASK DOCTOR/PHARMACIST
    5. OTC - PREGNANCY OR BREAST FEEDING
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. OTC - QUESTIONS
    8. DOSAGE & ADMINISTRATION
    9. WARNINGS
    10. INDICATIONS & USAGE
    11. INACTIVE INGREDIENT
    12. PROSTADERM PDP
    13. PROSTADERM DRUG FACTS

Prostaderm Product Label

The following document was submitted to the FDA by the labeler of this product Ezp Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredients                         Purpose

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


Otc - Purpose



Uses For the temporary relief of pain


Otc - When Using



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



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



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


Otc - Keep Out Of Reach Of Children



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



  • Questions?1-877-806-3569

Dosage & Administration



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



For external use only.

Do not use otherwise than as directed


Indications & Usage



Uses For the temporary relief of pain.


Inactive Ingredient



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


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