CSI COOLING PATCH- menthol 5% tape

CSI Cooling Patch by

Drug Labeling and Warnings

CSI Cooling Patch by is a Otc medication manufactured, distributed, or labeled by Shanghai Chuangshi Industry Group Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol

Inactive ingredient

Aloe barbadensis leaf extract
Arnica montana flower extract
Boswellia carterii resin extract
Camellia sinensis leaf extract
Diazolidinyl urea
Dihydroxyaluminun aminoacetate
Glycerin
Iodopropynyl butylcarbamate
Kaolin
Polyacrylic acid
Polysorbate 80
Propylene glycol
Pvp
Sodium polyacrylate
Tartaric acid
Titanium dioxide
Water

Purpose

Pain relief with cold therapy for sore muscles, backaches, and joint pain.

When using

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, sprains.

Do not use

Stop use

Buming discomfort or excessive skin irritation develops, condition worsens, or if symptoms persists for more than 7 days, or clear up and occur within few days.

Ask doctor

Buming discomfort or excessive skin irritation develops, condition worsens, or if symptoms persists for more than 7 days, or clear up and occur within few days.

If pregnant or breast-feeding.

Ask doctor/pharmacist

Buming discomfort or excessive skin irritation develops, condition worsens, or if symptoms persists for more than 7 days, or clear up and occur within few days.
If pregnant or breast-feeding.

Keep out of reach of children

Keep out of reach of children.

If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Questions

Please contact with us at the phone number +86-21-31166566 or email webmaster@csigroup.com.cn when you have any questions.

Pregnancy or breast feeding

Pregnant or breast feeding women shall follow doctor advice.

Indications & usage

* Adult and Children 12 year of age and older:
Clean and dry affected area, partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use.
* Children under 12 years of age:
Consult physician.

Dosage & administration

One patch at a time. Use it as needed, no more than 4 times daily.

For external use only.

Dosage forms & strengths

This is a patch, tape dosage form.

The active ingredient strength is 5%.

Warnings

For external use only.
Use only as directed.
Store in a cool dry place away from direct sunlight.

Package label. Principal display panel

Package

INGREDIENTS AND APPEARANCE

CSI COOLING PATCH 
menthol 5% tape

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73557-135
Route of Administration	CUTANEOUS, EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.05

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.25
POLYSORBATE 80 (UNII: 6OZP39ZG8H)	0.004
POVIDONE K30 (UNII: U725QWY32X)	0.05
GREEN TEA LEAF (UNII: W2ZU1RY8B0)	0.001
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.002
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)	0.0015
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)	0.002
FRANKINCENSE (UNII: R9XLF1R1WM)	0.001
KAOLIN (UNII: 24H4NWX5CO)	0.005
TARTARIC ACID (UNII: W4888I119H)	0.0025
WATER (UNII: 059QF0KO0R)	0.3474
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)	0.0011
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.05
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)	0.17
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)	0.0015
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)	0.06
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	0.001

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73557-135-05	5 in 1 BOX	01/28/2020
1	NDC: 73557-135-01	1 in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/28/2020

Labeler - Shanghai Chuangshi Industry Group Co., Ltd (546872672)

Registrant - Shanghai Chuangshi Industry Group Co., Ltd (546872672)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuangshi Industry Group Co., Ltd		546872672	manufacture(73557-135) , label(73557-135)