QUALI HERBAL- menthol, methyl salicylate patch 
Teh Seng Pharmaceutical Mfg. Co., Ltd

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.

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Teh Seng Pharmaceutical Mfg. Co., Ltd

ACTIVE INGREDIENTS

Menthol   10%

Methyl Salicylate   0.5%

Purpose

Menthol         Topical Analgesic

Methyl Salicylate       Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

Simple backache
Arthritis
Sprains
Strains
Bruises

Warnings

1. For external use only. Avoid applying around the eyes and mucous membranes, or open wounds.
2. Pregnant women, nursing mothers and any person with allergic reactions to drugs or cosmetics should consult physician before use. Children should use this product under supervision.

Stop Use

Discontinue if skin irritation develops.

Keep Out Of Reach of Children.

Keep out of reach of children.

Directions

1. Clean and dry the affected areas before application.
2. Remove the protective film while applying the areas 1-2 times daily, cut into smaller size if desired. If necessary up to 3 sheets per day.
3. Use only as directed. Firmly affix with adhesive tapes or elastic bandages around joint areas to secure the patch if needed.

Storage

Store at room temperature away from direct sunlight. Properly sealed to remain fresh.

Inactive Ingredients

ANGELICA SINENSIS ROOT, ANGELICA DAHURICA WHOLE, ALMOND, SCROPHULARIA NINGPOENSIS ROOT, GLEDITSIA SINENSIS WHOLE, LIQUIDAMBAR FORMOSANA RESIN, ALLIUM FISTULOSUM WHOLE, TURPENTINE, FRANKINCENSE, MYRRH, YELLOW WAX, ROSIN, ZINC OXIDE, SESAME OIL

U.S. Sole Agent

Finemost Corp., Qualiherb

Cerritos, Ca 90703

Tel:   (562)802-0035

Fax: (562)802-0625

Made in Taiwan

Drug Facts

image description

QUALI HERBAL 
menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67536-882
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
ANGELICA DAHURICA WHOLE (UNII: 667W6C5J4P)  
ALMOND (UNII: 3Z252A2K9G)  
SCROPHULARIA NINGPOENSIS ROOT (UNII: HC0FB6P85R)  
GLEDITSIA SINENSIS WHOLE (UNII: FS3UB95UTG)  
LIQUIDAMBAR FORMOSANA RESIN (UNII: 597LBL467J)  
ALLIUM FISTULOSUM WHOLE (UNII: 51BV41D79A)  
TURPENTINE (UNII: XJ6RUH0O4G)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
MYRRH (UNII: JC71GJ1F3L)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
ROSIN (UNII: 88S87KL877)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
SESAME OIL (UNII: QX10HYY4QV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67536-882-01100 in 1 BOX10/10/2013
116 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/10/2013
Labeler - Teh Seng Pharmaceutical Mfg. Co., Ltd (656347721)

Revised: 10/2016
Document Id: a2c1addd-a9d9-494e-b63d-fd26559bac2a
Set id: b120dc4a-743c-4653-9602-a4a65c848024
Version: 3216
Effective Time: 20161012
 
Teh Seng Pharmaceutical Mfg. Co., Ltd