NDC | 61821-051-01 |
Set ID | 9b083eb2-8700-421e-9681-146e7089e390 |
Category | HUMAN OTC DRUG LABEL |
Packager | GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- 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
■ 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
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
EXTRA STRENGTH HUA TUO MEDICATED PLASTER
camphor, menthol, methyl salicylate plasterProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61821-051 Route of Administration TOPICAL, TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 8.3 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.32 g MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ) MENTHYL SALICYLATE, (+/-)- 13.84 g Inactive Ingredients Ingredient Name Strength OCIMUM GRATISSIMUM WHOLE (UNII: 7V3N80T4VS) CINNAMON OIL (UNII: E5GY4I6YCZ) SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD) LIQUIDAMBAR FORMOSANA RESIN (UNII: 597LBL467J) GREATER GALANGAL (UNII: 7Y64R856MB) GINGER (UNII: C5529G5JPQ) GLECHOMA LONGITUBA TOP (UNII: D352074L9S) NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) ROSIN (UNII: 88S87KL877) SAFFLOWER (UNII: 4VBL71TY4Y) SCHIZONEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61821-051-01 5 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/17/2013 Labeler - GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY (654032218) Registrant - GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY (654032218) Establishment Name Address ID/FEI Business Operations GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY 654032218 manufacture(61821-051)