Label: TIANHE ZHUANGGU GAO- pain relieving plaster plaster
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Contains inactivated NDC Code(s)
NDC Code(s): 68007-203-01 - Packager: GUILIN TIANHE PHARMACEUTICAL CO LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated May 25, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- DO NOT USE
- WHEN USING
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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:
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- pain persists for more than 10 days
- redness is present
- in conditions affecting children under 12 years of age
- pain persists for more than 10 days
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions Clean the affected area. Remove the paper film from the plaster.
- adults and children 12 years of age and older: apply one plaster to affected area not more than 3 to 4 times daily
- children under 12 years of age: do not use, consult your physician
- refer to the above warnings; use otherwise than as directed may be dangerous
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TIANHE ZHUANGGU GAO
pain relieving plaster plasterProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68007-203 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 3.22 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.39 g METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 15.01 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68007-203-01 10 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/25/2010 Labeler - GUILIN TIANHE PHARMACEUTICAL CO LTD (528565427) Establishment Name Address ID/FEI Business Operations GUILIN TIANHE PHARMACEUTICAL CO LTD 528565427 manufacture