YUNNAN BAIYAO ARTHRITIS PAIN RELIEF- camphor, capsaicin, methyl salicylate plaster

YUNNAN BAIYAO ARTHRITIS PAIN RELIEF by

Drug Labeling and Warnings

YUNNAN BAIYAO ARTHRITIS PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by YUNNAN BAIYAO GROUP CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Camphor 11%
Capsaicin 0.25%
Methyl salicylate 14.24%

PURPOSE

Purpose
External analgesic
External analgesic
External analgesic

INDICATIONS & USAGE

Uses For the temporary relief of minor aches and pains of muscles and joints due to:

• simple backache
• arthritis
• strains
• bruises
• sprains

WARNINGS

Warnings
For external use only


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

DO NOT USE

Do not use

• on irritated or damaged skin
• on wounds
• otherwise than as directed

WHEN USING

When using this product

• avoid contact with the eyes or mucous membranes
• do not bandage tightly

STOP USE

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

• 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

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

DOSAGE & ADMINISTRATION

Directions

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

• refer to the above warnings; use otherwise than as directed may be dangerous

STORAGE AND HANDLING

Other information

• keep tightly closed

• store at 15° to 30° C (59° to 86° F)

INACTIVE INGREDIENT

Inactive ingredients Peppermint oil, petrolatum, lanolin, rosin, and zinc oxide, on a natural latex rubber pad.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

YUNNAN BAIYAO ARTHRITIS PAIN RELIEF PLASTER
External Analgesic
NDC: 61658-001-01
Camphor 11%, Capsaicin 0.25%, Methyl Salicylate 14.24%
6 Plasters
Each Plaster 7 x 10 cm (2.76 x 3.94 in)

INGREDIENTS AND APPEARANCE

YUNNAN BAIYAO ARTHRITIS PAIN RELIEF 
camphor, capsaicin, methyl salicylate plaster

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61658-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	128.04 mg
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	2.88 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	168.03 mg

Inactive Ingredients
Ingredient Name	Strength
PEPPERMINT OIL (UNII: AV092KU4JH)
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
ROSIN (UNII: 88S87KL877)
ZINC OXIDE (UNII: SOI2LOH54Z)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61658-001-01	1 in 1 BOX
1		6 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/18/2015

Labeler - YUNNAN BAIYAO GROUP CO., LTD. (654223122)

Establishment
Name	Address	ID/FEI	Business Operations
YUNNAN BAIYAO GROUP CO., LTD.		654223122	manufacture(61658-001)