QUALI WARM- menthol, methyl salicylate patch

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Menthol 3.0%, Methyl Salicylate 0.8%
Available from:
Teh Seng Pharmaceutical Mfg. Co., Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Menthol                    Topical Analgesic Methyl Salicylate       Topical Analgesic For temporary relief of minor aches and pains of muscles and joints associated with: Simple backache Arthritis Sprains Strains Bruises Discontinue if skin irritation develops.
Authorization status:
OTC monograph not final
Authorization number:
67536-883-01

QUALI WARM- 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 3.0%

Methyl Salicylate 0.8%

Purpos e

Menthol Topical Analgesic

Methyl Salicylate Topical Analgesic

Us es

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

Ginger, Gelatin, Frankincense, Myrrh, Rosin, Turpentine, Zinc Oxide

U.S. Sole Agent

Finemost Corp., Qualiherb

Cerritos, Ca 90703

Tel: (562)802-0035

Fax: (562)802-0625

Made in Taiwan

Drug Facts

QUALI WARM

menthol, methyl salicylate patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 7536 -8 8 3

Teh Seng Pharmaceutical Mfg. Co., Ltd

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

3 g in 10 0 g

METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

METHYL SALICYLATE

0 .8 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

GINGER (UNII: C5529 G5JPQ)

GELATIN (UNII: 2G8 6 QN327L)

FRANKINCENSE (UNII: R9 XLF1R1WM)

MYRRH (UNII: JC71GJ1F3L)

RO SIN (UNII: 8 8 S8 7KL8 77)

TURPENTINE (UNII: XJ6 RUH0 O4G)

ZINC O XIDE (UNII: SOI2LOH54Z)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 7536 -8 8 3-0 1

10 0 in 1 BOX

10 /10 /20 13

1

16 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

10 /10 /20 13

Labeler -

T eh Seng Pharmaceutical Mfg. Co., Ltd (656347721)

Revised: 10/2016

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