PROSTADERM- camphor plaster

Prostaderm by

Drug Labeling and Warnings

Prostaderm by is a Otc medication manufactured, distributed, or labeled by EZP Corporation, Jinzhou Zijing Pharmaceutical Co., Jinzhou Zijing Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                         Purpose

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

PURPOSE

Uses For the temporary relief of pain

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

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.

PREGNANCY OR BREAST FEEDING

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

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

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

• Adults: Apply to affected area for 24-48 hours
• Children under 18 years of age: Ask 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

Prostaderm PDP

Prostaderm Drug Facts

INGREDIENTS AND APPEARANCE

PROSTADERM 
camphor plaster

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69446-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3   in 100

Inactive Ingredients
Ingredient Name	Strength
CISTANCHE DESERTICOLA STEM (UNII: 45BEI4ZF64)
SYZYGIUM AROMATICUM WHOLE (UNII: EY9MMA0P6Y)
COMMIPHORA MYRRHA WHOLE (UNII: UU81N77RI7)
CORYDALIS BUNGEANA WHOLE (UNII: 732H9A883V)
DICTAMNUS DASYCARPUS ROOT BARK (UNII: LA97176ILS)
FOENICULUM VULGARE WHOLE (UNII: J1UK54JBGH)
MOSCHUS MOSCHIFERUS MUSK SAC RESIN (UNII: 8KFK4W7KP7)
POLYVINYL ALCOHOL (UNII: 532B59J990)
GLYCEROL FORMAL (UNII: 3L7GR2604E)
LAUROCAPRAM (UNII: 1F3X9DRV9X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69446-100-01	1 in 1 PACKAGE	02/24/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/24/2015

Labeler - EZP Corporation (039212541)

Registrant - Jinzhou Zijing Pharmaceutical Co. (527929247)

Establishment
Name	Address	ID/FEI	Business Operations
Jinzhou Zijing Pharmaceutical Co., Ltd.		527929247	manufacture(69446-100)