NDC | 61658-001-01 |
Set ID | 03a66422-3586-4af9-a9b0-aaebda14b10d |
Category | HUMAN OTC DRUG LABEL |
Packager | YUNNAN BAIYAO GROUP CO., LTD. |
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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
YUNNAN BAIYAO ARTHRITIS PAIN RELIEF
camphor, capsaicin, methyl salicylate plasterProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61658-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 128.04 mg CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 2.88 mg METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 168.03 mg Inactive Ingredients Ingredient Name Strength PEPPERMINT OIL (UNII: AV092KU4JH) PETROLATUM (UNII: 4T6H12BN9U) LANOLIN (UNII: 7EV65EAW6H) ROSIN (UNII: 88S87KL877) ZINC OXIDE (UNII: SOI2LOH54Z) NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61658-001-01 1 in 1 BOX 1 6 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 06/18/2015 Labeler - YUNNAN BAIYAO GROUP CO., LTD. (654223122) Establishment Name Address ID/FEI Business Operations YUNNAN BAIYAO GROUP CO., LTD. 654223122 manufacture(61658-001)