Finemost Corporation

Finemost Corporation

Drug Labeling and Warnings

Drug Details

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QUALI PATCH (COLD)- methyl salicylate, menthol, camphor patch 
Finemost Corporation

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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Finemost Corporation

ACTIVE INGREDIENTS

Methyl Salicylate    2.0%

Menthol     1.0%

Camphor      0.5%

Purpose

Methyl Salicylate     Topical Analgesic

Menthol     Topical Analgesic

Camphor     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

Phellodendron Amurense Whole

Distributed by

Finemost Corp. DBA QualiHerb

Cerritos, Ca 90703

Tel:   (562)802-0035

Fax: (562)802-0625

Made in Taiwan

Drug Facts

image description

QUALI PATCH (COLD) 
methyl salicylate, menthol, camphor patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 72026-881
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE2 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PHELLODENDRON AMURENSE WHOLE (UNII: 3OZN5NGR9L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 72026-881-01100 in 1 BOX10/10/201310/10/2033
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 finalpart34810/10/201310/10/2033
Labeler - Finemost Corporation (623264082)

Revised: 1/2018
 
Finemost Corporation


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