Label: 701 DIEDA ZHENGTONG YAOGAO MEDICATED- camphor and menthol plaster
- NDC Code(s): 55614-620-01, 55614-620-02
- Packager: MADISON ONE ACME INC
- 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 4, 2020
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR/PHARMACIST
- WHEN USING
-
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 - ADVERSE REACTIONS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
-
INACTIVE INGREDIENT
Inactive ingredients
Angelica dahurica root, butylated hydroxytoluene, cinnamon oil, ginger, lanolin, light mineral oil, methyl salicylate, natural latex rubber, nepeta tenuifolia flowering top, ocimum gratissimum leaf oil, petrolatum, polyisobutylene, reynoutria japonica root, rheum officinale root, rosin, safflower, saposhnikovia divaricata root, scutellaria baicalensis root, zanthoxylum nitidum root and zinc oxide on an elastic cloth backing and covered with a polyethylene film. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
701 DIEDA ZHENGTONG YAOGAO MEDICATED
camphor and menthol plasterProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55614-620 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 3.1 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g in 100 g Inactive Ingredients Ingredient Name Strength ANGELICA DAHURICA ROOT (UNII: 1V63N2S972) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CINNAMON OIL (UNII: E5GY4I6YCZ) GINGER (UNII: C5529G5JPQ) LANOLIN (UNII: 7EV65EAW6H) LIGHT MINERAL OIL (UNII: N6K5787QVP) METHYL SALICYLATE (UNII: LAV5U5022Y) NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) NEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE) OCIMUM GRATISSIMUM LEAF OIL (UNII: AVG2506KDV) PETROLATUM (UNII: 4T6H12BN9U) POLYISOBUTYLENE (800000 MW) (UNII: Y132ZOQ9H7) REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7) RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M) ROSIN (UNII: 88S87KL877) SAFFLOWER (UNII: 4VBL71TY4Y) SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) ZANTHOXYLUM NITIDUM ROOT (UNII: L2CQZ81759) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55614-620-02 1 in 1 CAN 05/04/2020 1 1 in 1 POUCH 1 1 g in 1 PATCH; Type 0: Not a Combination Product 2 NDC:55614-620-01 10 in 1 BOX 05/04/2020 2 4 in 1 POUCH 2 1 g in 1 PATCH; 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 05/04/2020 Labeler - MADISON ONE ACME INC (096196758) Establishment Name Address ID/FEI Business Operations Zhejiang Dingtai Pharmaceutical Co., Ltd 420598724 manufacture(55614-620)