Label: QIAN LI ZHUI FENG PAIN RELIEVING- camphor, menthol, and methyl salicylate oil
- NDC Code(s): 55614-690-01
- 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 March 23, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
QIAN LI ZHUI FENG PAIN RELIEVING
camphor, menthol, and methyl salicylate oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55614-690 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 10 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 15 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 48 g in 100 mL Inactive Ingredients Ingredient Name Strength ANGELICA BISERRATA ROOT (UNII: OJ90180B22) ANGELICA SINENSIS ROOT (UNII: B66F4574UG) CHAENOMELES LAGENARIA FRUIT (UNII: XBC17A15MU) CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU) CORYDALIS YANHUSUO TUBER (UNII: 0TUP42692Z) GENTIANA MACROPHYLLA ROOT (UNII: 6559FC0U1B) LAVENDER OIL (UNII: ZBP1YXW0H8) MINERAL OIL (UNII: T5L8T28FGP) SINOMENIUM ACUTUM STEM (UNII: BBH96IEM66) TAXILLUS CHINENSIS TOP (UNII: QJ523LD71P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55614-690-01 1 in 1 BOX 10/27/2020 1 50 mL in 1 BOTTLE, GLASS; 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 10/27/2020 Labeler - MADISON ONE ACME INC (096196758) Establishment Name Address ID/FEI Business Operations Zhejiang Dingtai Pharmaceutical Co., Ltd 420598724 manufacture(55614-690)