OTC Medication Information: WU YANG BRAND PAIN RELIEVING MEDICATED

WU YANG BRAND PAIN RELIEVING MEDICATED- menthol and camphor (synthetic) plaster
MADISON ONE ACME INC

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
Menthol 5%
Camphor 3%

Purpose
External analgesic
External analgesic

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

Warnings
For external use only

Do not use
■ on wounds
■ on damaged or irritated skin
■ if excessive irritation develops
■ otherwise than as directed, to do so may be dangerous

When using this product
■ avoid contact with the eyes or mucous membranes
■ do not bandage tightly

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
■ when using for pain of arthritis if:
■ 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 to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
■ Adults and children 2 years of age and older: Cut to desired size, remove clear backing, and apply to affected area not more than 3 to 4 times daily.
■ Children under 2 years of age: Do not use, consult a doctor.

Other information
■ store at 15º to 30º C (59º to 86º F) in a dry place away from sunlight

Inactive ingredients
angelica dahurica root, butylated hydroxytoluene, cinnamon oil, dipsacus asper root, dragon’s blood, drynaria fortunei root, gardenia jasminoides fruit, ginger, lanolin, light mineral oil, lonicera japonica flower, methyl salicylate, myrrh, natural latex rubber, nepeta tenuifolia flowering top, petrolatum, polyisobutylene, rheum officinale root, rosin, safflower, saposhnikovia divaricata root, senegalia catechu wood, taraxacum mongolicum whole, zanthoxylum nitidum root and zinc oxide.

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

WU YANG BRAND PAIN RELIEVING MEDICATED PLASTER

External Analgesic

NDC 55614-700-01

Large Pain Relief Patches

10 PlastersEach plaster 3.9 x 11 inches (10 x 28 cm) — 1 Plaster per pouch

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

WU YANG BRAND PAIN RELIEVING MEDICATED PLASTER

External Analgesic

NDC 55614-700-02

Cut To Size Pain Relief Patches

1 Plaster
3.9 x 78.7 inches (10 x 200 cm)

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

WU YANG BRAND PAIN RELIEVING MEDICATED menthol and camphor plaster
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55614-700
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 5 g in 100 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ANGELICA DAHURICA ROOT
BUTYLATED HYDROXYTOLUENE
CINNAMON OIL
DIPSACUS ASPER ROOT
DRAGON’S BLOOD
DRYNARIA FORTUNEI ROOT
GARDENIA JASMINOIDES FRUIT
GINGER
LANOLIN
LIGHT MINERAL OIL
LONICERA JAPONICA FLOWER
METHYL SALICYLATE
MYRRH
NATURAL LATEX RUBBER
NEPETA TENUIFOLIA FLOWERING TOP
PETROLATUM
POLYISOBUTYLENE (800000 MW)
RHEUM OFFICINALE ROOT
ROSIN
SAFFLOWER
SAPOSHNIKOVIA DIVARICATA ROOT
SENEGALIA CATECHU WOOD
TARAXACUM MONGOLICUM WHOLE
ZANTHOXYLUM NITIDUM ROOT
ZINC OXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55614-700-01 10 POUCH in 1 BOX contains a POUCH
1 1 PATCH in 1 POUCH This package is contained within the BOX (55614-700-01) and contains a PATCH
1 1 g in 1 PATCH This package is contained within a POUCH and a BOX (55614-700-01)
2 NDC:55614-700-02 1 PATCH in 1 CANISTER contains a PATCH
2 1 g in 1 PATCH This package is contained within the CANISTER (55614-700-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 08/31/2020
Labeler — MADISON ONE ACME INC (096196758)
Establishment
Name Address ID/FEI Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd 420598724 manufacture (55614-700)

Revised: 01/2021 MADISON ONE ACME INC

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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