Label: ZHUANGGU GAO PAIN RELIEVING- menthol plaster
- NDC Code(s): 68007-402-01
- Packager: GUILIN CHINA RESOURCES 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 10, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR/PHARMACIST
-
WHEN USING
When using this product
■ avoid contact with the eyes or mucous membranes
■ do not bandage tightly
■ do not apply heat to the area in 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
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
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ZHUANGGU GAO PAIN RELIEVING
menthol plasterProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68007-402 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 35 mg Inactive Ingredients Ingredient Name Strength ANGELICA SINENSIS ROOT (UNII: B66F4574UG) ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O) ANGELICA DAHURICA ROOT (UNII: 1V63N2S972) GINGER (UNII: C5529G5JPQ) KAEMPFERIA GALANGA ROOT (UNII: 7B7U9D12AI) LANOLIN (UNII: 7EV65EAW6H) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) ROSIN (UNII: 88S87KL877) NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) STAR ANISE FRUIT (UNII: CK15HA8438) STYRENE (UNII: 44LJ2U959V) ISOPRENE (UNII: 0A62964IBU) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68007-402-01 2 in 1 BOX 05/10/2021 1 5 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 05/10/2021 Labeler - GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD (528565427) Establishment Name Address ID/FEI Business Operations GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD 528565427 manufacture(68007-402)