PLASTER MANDAHERBALPLASTER- menthol patch 
Dah Wei Chem & Pharm Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

MandAHerbalPlaster

Active ingredients: (each 5 g patch contains)                                 PURPOSE
METHYL SALICYLATE  250 mg                                         EXTERNAL ANALGESIC
L-METHENOL -  200 mg                                                    EXTERNAL ANALGESIC
CAMPHOR –   40mg                                                         EXTERNAL ANALGESIC
SESAME OIL – 500 mg                                                     EXTERNAL ANALGESIC
MYRRH – 150mg                                                              EXTERNAL ANALGESIC                                     
                                  

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis strains, bruises and sprains.

For external use only

Remove the clear backing and apply to thew sore area of skin.

■ Keep container tightly closed, once opened, fold the opening and keep pressed closed with a clip.
■ Store at room temperature.

Inactive ingredient: Resin


Stop use and ask a doctor if:
■ Condition worsens
■ Symptom clear up and occur again within a few days.
■ Symptom persist for more than 7 days.
■ Nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
■ Excessive irritation of the skin develops
■ When using for pain of arthritis:
■ In conditions affecting children under 12 years of age
■ If red nose is present
■ If pain persists for more than 10 days 

Keep out reach of children to avoid accidental poisoning. If swallowed, get medical help or consult a poison control center right away.

Do not use:
■ On wounds
■ On infected or damaged skin
When using this product:
■ Avoid contact with eyes or mucous membranes.
■ Do not bandage tightly.

PURPOSE

EXTERNAL ANALGESIC

MandAHerbalPlaster

PLASTER  MANDAHERBALPLASTER
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14319-3118
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.2 g  in 30 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE1.5 g  in 30 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.24 g  in 30 g
MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L) MYRRH.90 g  in 30 g
SESAME OIL (UNII: QX10HYY4QV) (SESAME OIL - UNII:QX10HYY4QV) SESAME OIL3.00 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
PINUS TABULIFORMIS BARK (UNII: 3G75L8C3RU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14319-3118-56 in 1 POUCH
130 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/25/2005
Labeler - Dah Wei Chem & Pharm Co., Ltd. (656347770)

Revised: 6/2011
Document Id: a4f660cb-f504-4f9c-9c3b-5cb4faf0d07a
Set id: c2207dbf-4b12-4742-bc29-8f7ec317475a
Version: 1
Effective Time: 20110608
 
Dah Wei Chem & Pharm Co., Ltd.