CSI Elastic Relief Strip, 5 Strips

Elastic Relief Strip by

Drug Labeling and Warnings

Elastic Relief Strip 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]

ELASTIC RELIEF STRIP- 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.

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CSI Elastic Relief Strip, 5 Strips

Active ingredient

Menthol 5.6% ...... Purpose: Cooling Pain Relief

Purpose

Cooling Pain Relief

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
• 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 overwrap or wrap strips over themselves
• Do not bandage or use with heating pad or device

Ask doctor

Stop use and ask a doctor if: You experience pain, swelling or blistering; condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

When using

• Use only as directed
• 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 overwrap or wrap strips over themselves
• Wash hands after use with cool water
• Do not bandage or use with heating pad or device

Do not use

• 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 overwrap or wrap strips over themselves
• Do not bandage or use with heating pad or device

Stop use

Stop use and ask a doctor if: You experience pain, swelling or blistering; 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 breastfeeding: 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 strip to site of pain. Carefully remove remaining film while pressing the strip to the skin and leave in place for up to 4 hours. Do not strech the strip during application as it should be comfortable and not tight. Use on affected areas not more than 4 times daily. For best adhesion: area should be clean, dry, and smooth.
• Children under 12 years of age: Consult physician

Dosage forms & strengths

This is a strip, patch dosage form.

The active ingredient strength is 5.6%.

Inactive ingredients

Questions

Questions or comments: 86-21-31166566

Other information

• Store in a cool dry place away from direct sunlight

Package label. Principal display panel

ELASTIC RELIEF STRIP 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73557-136
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.056 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)	0.30808 g  in 1 g
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)	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
BENZODODECINIUM CHLORIDE (UNII: Y5A751G47H)	0.001 g  in 1 g
NONOXYNOL-10 (UNII: K7O76887AP)	0.00002 g  in 1 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.005 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: 73557-136-05	5 in 1 BOX	04/28/2021	12/30/2022
1	NDC: 73557-136-01	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	04/28/2021	12/30/2022

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(73557-136) , label(73557-136)

Revised: 12/2022

Document Id: f1050a38-94c3-91b4-e053-2a95a90a1ab0

34390-5

Set id: c0f4e133-41ac-5a14-e053-2995a90a1f00

Version: 2

Effective Time: 20221229

 

Shanghai Chuang