NDC | 69070-307-01 |
Set ID | 9850754b-ac94-4ec6-b75a-8096e5ac9456 |
Category | HUMAN OTC DRUG LABEL |
Packager | Zhejiang Dingtai Pharmaceutical Co., Ltd |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- 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 the 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 - ADVERSE REACTIONS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
-
INACTIVE INGREDIENT
Inactive ingredients
Ocimum gratissimum leaf oil, butylated hydroxytoluene, cinnamon oil, saposhnikovia divaricata root, angelica dahurica root, ginger, lanolin, natural latex rubber, petrolatum, rosin, safflower, nepeta tenuifolia flowering top, and zinc oxide on an elastic cloth and covered with a protective paper film. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
EXTRA STRENGTH HUA TUO PAIN RELIEVING
camphor and menthol plasterProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69070-307 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 2.6 g in 100 g Inactive Ingredients Ingredient Name Strength OCIMUM GRATISSIMUM LEAF OIL (UNII: AVG2506KDV) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CINNAMON OIL (UNII: E5GY4I6YCZ) SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD) ANGELICA DAHURICA ROOT (UNII: 1V63N2S972) GINGER (UNII: C5529G5JPQ) LANOLIN (UNII: 7EV65EAW6H) NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) PETROLATUM (UNII: 4T6H12BN9U) ROSIN (UNII: 88S87KL877) SAFFLOWER (UNII: 4VBL71TY4Y) NEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69070-307-01 1 in 1 BOX 04/09/2019 1 5 in 1 POUCH 1 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 04/09/2019 Labeler - Zhejiang Dingtai Pharmaceutical Co., Ltd (420598724) Establishment Name Address ID/FEI Business Operations Zhejiang Dingtai Pharmaceutical Co., Ltd 420598724 manufacture(69070-307)