Prostaderm
FDA Label NDC 69446-100

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ezp Corporation for the product Prostaderm (NDC 69446-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - when using, otc - ask doctor/pharmacist, otc - pregnancy or breast feeding, otc - keep out of reach of children, otc - questions, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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