FDA Label for Plaster Mandaherbalplaster

View Indications, Usage & Precautions

Plaster Mandaherbalplaster Product Label

The following document was submitted to the FDA by the labeler of this product Dah Wei Chem & Pharm Co., Ltd.. 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: (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                                     
                                  


Indications & Usage



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


Warnings



For external use only


Dosage & Administration



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


Storage And Handling



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


Inactive Ingredient



Inactive ingredient: Resin


Otc - Ask Doctor




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 


Otc - Keep Out Of Reach Of Children



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


Otc - Do Not Use



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


Package Label.Principal Display Panel




* Please review the disclaimer below.