XXX_CSI MENTHOL PAIN RELIEF PATCH, 5 Patches

MENTHOL PAIN RELIEF by

Drug Labeling and Warnings

MENTHOL PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Shanghai Chuangshi Medical Technology (Group) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MENTHOL PAIN RELIEF- menthol patch 
Shanghai Chuangshi Medical Technology (Group) 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.

----------

XXX_CSI MENTHOL PAIN RELIEF PATCH, 5 Patches

Active ingredient

Menthol 5.6% ...... Purpose: Topical Analgesic

Purpose

Topical Analgesic

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with:

• arthrits
• backache
• strains
• sprains

Warnings

• For external use only
• Use only as directed
• Do not bandage tightly or use with heating pad or device
• Avoid contact with eyes or mucous membranes
• Do not apply to wounds or damaged skin
• Do not use with other ointments, creams, sprays, or liniments
• Do not apply to irritated skin

Ask doctor

Ask a doctor before use if you have: Sensitive skin

Stop use and ask a doctor if: Burning disconfort or excessive skin irritation develops, condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

If pregnant or breast-feeding: Ask a health professional before use

When using

For external use only

• Use only as directed
• Do not bandage tightly or use with heating pad or device
• Avoid contact with eyes or mucous membranes
• Do not apply to wounds or damaged skin
• Do not use with other ointments, creams, sprays, or liniments
• Do not apply to irritated skin

Do not use

• Use only as directed
• Do not bandage tightly or use with heating pad or device
• Avoid contact with eyes or mucous membranes
• Do not apply to wounds or damaged skin
• Do not use with other ointments, creams, sprays, or liniments
• Do not apply to irritated skin

Stop use

Stop use and ask a doctor if: Burning disconfort or excessive skin irritation develops, condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

Pregnancy or breast feeding

If pregnant or breast-feeding: Ask a health professional before use

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

Directions

• Adult and Children 12 years 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 forms & strengths

This is patch dosage form.

The active ingredient strength is 5%.

Inactive ingredients

Water, Glycerin, Polyacrylic acid, Propylene glycol, Sodium polyacrylate, Mineral oil, Polysorbate 80, PVP, Petrolatum, Dihydroxyaluminum aminoacetate, Edetate disodium, Kaolin, Carboxymethylcellulose sodium, Titanium dioxide,
L-Tartaric acid, Benzalkonium chloride, Lauralkonium chloride, Aloe barbadensis leaf extract, Arnica montana flower extract, Boswellia carterii resin extract, Camellia sinensis leaf extract

Questions

Questions or comments: 86-21-31166566

Other information

• Store in a cool dry place away from direct sunlight

Package label. Principal display panel

MENTHOL PAIN RELIEF 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73557-137
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)	0.018 g  in 1 g
GLYCERIN (UNII: PDC6A3C0OX)	0.24 g  in 1 g
POVIDONE K30 (UNII: U725QWY32X)	0.012 g  in 1 g
GREEN TEA LEAF (UNII: W2ZU1RY8B0)	0.0001 g  in 1 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.0001 g  in 1 g
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.001 g  in 1 g
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)	0.0001 g  in 1 g
FRANKINCENSE (UNII: R9XLF1R1WM)	0.0001 g  in 1 g
KAOLIN (UNII: 24H4NWX5CO)	0.001 g  in 1 g
TARTARIC ACID (UNII: W4888I119H)	0.001 g  in 1 g
WATER (UNII: 059QF0KO0R)	0.3191 g  in 1 g
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)	0.0015 g  in 1 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.07 g  in 1 g
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)	0.2 g  in 1 g
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)	0.001 g  in 1 g
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)	0.05 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	0.001 g  in 1 g
MINERAL OIL (UNII: T5L8T28FGP)	0.03 g  in 1 g
PETROLATUM (UNII: 4T6H12BN9U)	0.002 g  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)	0.001 g  in 1 g
LAURALKONIUM CHLORIDE (UNII: 07HUP5A29X)	0.001 g  in 1 g

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73557-137-05	5 in 1 BOX	08/13/2021	08/19/2021
1	NDC: 73557-137-01	5 g in 1 PATCH; 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	08/13/2021	08/19/2021

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.		546872672	manufacture(73557-137) , label(73557-137)

Revised: 8/2021

Document Id: c9eaebc2-2c09-9854-e053-2a95a90a68c4

34390-5

Set id: c972b44c-d930-8428-e053-2995a90a026a

Version: 2

Effective Time: 20210819

 

Shanghai Chuang