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.

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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

137-1137-5

MENTHOL PAIN RELIEF 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73557-137
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.05 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73557-137-055 in 1 BOX08/13/202108/19/2021
1NDC: 73557-137-015 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/13/202108/19/2021
Labeler - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)
Registrant - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.546872672manufacture(73557-137) , label(73557-137)

Revised: 8/2021
 
Shanghai Chuang

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