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EXTRA STRENGTH HUA TUO MEDICATED PLASTER

Medically reviewed on June 18, 2018

Dosage form: plaster
Ingredients: CAMPHOR (SYNTHETIC) 8.3g, MENTHOL 3.32g, MENTHYL SALICYLATE, (+/-)- 13.84g
Labeler: GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY
NDC Code: 61821-051

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.

Drug Facts

Active ingredients
Camphor 8.3%
Menthol 3.32%
Methyl salicylate 13.84%

Purpose
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

Do not use
■ on irritated or damaged skin ■ on wounds ■ otherwise than as directed

When using this product
■ avoid contact with the eyes or mucous membranes
■ do not bandage tightly
■ 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
■ 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 to avoid accidental poisoning.
If swallowed, get medical help or contact a Poison Control Center right away.

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

Other information
■ keep in a tightly closed container
■ store at 15º to 30º C (59º to 86º F)

Inactive ingredients
African basil (Ocimum gratissimum L) herb oil, cinnamon oil, fang feng root, Formosan sweet gum (Liquidambar formosana Hance) Resin,
fragrant angelica root extract, greater galangal root extract, ginger root extract, huo xue dan [Glechoma longituba (Nakai) Kuprian] aerial part,
natural latex rubber, nux vomica (Strychnos nux-vomica L) seed, rosin, safflower flower, and schizonepeta (Schizonepeta tenuifolia Briq.) flowering
aerial part 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


EXTERNAL ANALGESIC
NDC 61821-051-01
EXTRA STRENGTH HUA TUO MEDICATED PLASTER
5 Plasters per Carton
Each Plaster 7x10 cm (2.76 x 3.94 in)

EXTRA STRENGTH HUA TUO MEDICATED PLASTER  
camphor, menthol, methyl salicylate plaster
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61821-051
Route of AdministrationTOPICAL, TRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)8.3 g
MENTHOL (MENTHOL) MENTHOL3.32 g
MENTHYL SALICYLATE, (+/-)- (SALICYLIC ACID) MENTHYL SALICYLATE, (+/-)-13.84 g
Inactive Ingredients
Ingredient NameStrength
OCIMUM GRATISSIMUM WHOLE 
CINNAMON OIL 
SAPOSHNIKOVIA DIVARICATA ROOT 
LIQUIDAMBAR FORMOSANA RESIN 
GREATER GALANGAL 
GINGER 
GLECHOMA LONGITUBA TOP 
NATURAL LATEX RUBBER 
STRYCHNOS NUX-VOMICA SEED 
ROSIN 
SAFFLOWER 
SCHIZONEPETA TENUIFOLIA FLOWERING TOP 
Packaging
#Item CodePackage Description
1NDC:61821-051-015 PLASTER (PATCH) in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/17/2013
Labeler - GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY (654032218)
Registrant - GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY (654032218)
Establishment
NameAddressID/FEIOperations
GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY654032218manufacture(61821-051)

 
GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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