OTC Medication Information: E MEI SHAN MEDICATED

E MEI SHAN MEDICATED- camphor (synthetic) and menthol plaster
Zhejiang Dingtai Pharmaceutical 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.

Active Ingredients
Camphor 3.1%
Menthol 2.6%

Purpose
External Analgesic
External Analgesic

Uses
For the temporary relief of minor aches and pains of muscles and joints due to:
■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Warnings
For external use only

Allergy alert: This product contains natural rubber latex which may cause allergic reactions

Report any unexpected side effects from the use of this product to the FDA MedWatch Program

Do not use
■ on irritated or damaged skin ■ on wounds

Ask a doctor or pharmacist before use if you have
■ any concerns about using this product

When using this product
■ avoid contact with the eyes or mucous membranes
■ do not bandage tightly
■ do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)
■ avoid placing on extremely hairy areas of skin to avoid irritation upon removing the plaster

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
■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)
■ when using for pain of arthritis:
■ pain persists for more than 10 days ■ redness is present
■ in conditions affecting children under 12 years of age

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
■ adults and children 2 years of age and older: remove the protective film from the plaster. Apply to affected area not more than 3 to 4 times daily.
■ children under 2 years of age: consult your physician

Other information
■ keep plasters tightly closed in the zip-lock pouch
■ store at 15º to 30º C (59º to 86º F) in a dry place away from sunlight

Inactive ingredients
Butylated hydroxytoluene, dong quai root, fragrant angelica root, ginger root, lanolin, light mineral oil, natural latex rubber, petrolatum, rosin, star anise fruit, and zinc oxide on a cotton pad

Questions or comments?
(888) 221-3496 M-F 9 am to 5 pm
■ you may also report serious side effects to this phone number

E MEI SHAN MEDICATED PLASTER

NDC 69070-300-01

Simple backache, Arthritis, Strains, Bruises, Sprains

5 Plaster
Each Plaster 7 x 10 cm (2.76 x 3.94 in)

IMAGE OF CARTON
(click image for full-size original)

E MEI SHAN MEDICATED camphor, menthol plaster
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69070-300
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 31 mg
MENTHOL (MENTHOL) MENTHOL 26 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
ANGELICA SINENSIS ROOT
ANGELICA DAHURICA ROOT
GINGER
LANOLIN
LIGHT MINERAL OIL
NATURAL LATEX RUBBER
PETROLATUM
ROSIN
STAR ANISE
ZINC OXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69070-300-01 1 POUCH in 1 BOX contains a POUCH
1 5 PLASTER in 1 POUCH This package is contained within the BOX (69070-300-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 09/17/2018
Labeler — Zhejiang Dingtai Pharmaceutical Co., Ltd (420598724)
Establishment
Name Address ID/FEI Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd 420598724 manufacture (69070-300)

Revised: 09/2018 Zhejiang Dingtai Pharmaceutical Co., Ltd

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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