CSI MENTHOL OVERNIGHT RELIEF GEL-PATCH, 5 Patches

OVERNIGHT RELIEF Gel-Patch by

Drug Labeling and Warnings

OVERNIGHT RELIEF Gel-Patch 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]

OVERNIGHT RELIEF GEL-PATCH- 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 MENTHOL OVERNIGHT RELIEF GEL-PATCH, 5 Patches

Active ingredient

Menthol 5% w/w ...... Purpose: Topical analgesic

Purpose

Topical analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthrits
  • strains
  • bruises
  • sprains

Warnings

For external use only

When using this prudocts:

use only as directed
avoid contact with eyes or on mucous membranes
do not apply to wounds or damaged skin
do not apply to irritated skin or if excessive irritation develops
do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if:
you experience pain, swelling or blistering of the skin
condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
arthritic pain persists for more than 10 days, or redness is present

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately

Ask doctor

Stop use and ask a doctor if:
you experience pain, swelling or blistering of the skin
condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
arthritic pain persists for more than 10 days, or redness is present

If pregnant or breastfeeding, ask a health professional before use.

When using

When using this prudocts:

use only as directed
avoid contact with eyes or on mucous membranes
do not apply to wounds or damaged skin
do not apply to irritated skin or if excessive irritation develops
do not bandage tightly or use with heating pad or device

Do not use

do not apply to wounds or damaged skin
do not apply to irritated skin or if excessive irritation develops
do not bandage tightly or use with heating pad or device

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 breastfeeding, ask a health professional before use.

Keep out of reach of children

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

Directions

adults and children 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed gel-patch to site of pain. Carefully remove remaining film while pressing the gel-patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 3 to 4 times daily.
children under 12 years of age: consult a physician
wash hands after use with cool water

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, Lavender Essential Oil, Polysorbate 80, PVP, Petrolatum, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Kaolin, Carboxymethylcellulose Sodium, Titanium Dioxide, L-Tartaric Acid, Benzalkonium Chloride, Lauralkonium Chloride

Questions or comments

Questions or comments: 86-21-31166566

Other information

store at 20-25℃ (68-77℉)

store in a cool dry place away from direct sunlight

Package label. Principal display panel

139-01139-05

OVERNIGHT RELIEF GEL-PATCH 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73557-139
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
KAOLIN (UNII: 24H4NWX5CO) 0.001 g  in 1 g
TARTARIC ACID (UNII: W4888I119H) 0.001 g  in 1 g
WATER (UNII: 059QF0KO0R) 0.3095 g  in 1 g
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) 0.0015 g  in 1 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.06 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 (2500000 MW) (UNII: 05I15JNI2J) 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
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
LAVENDER OIL (UNII: ZBP1YXW0H8) 0.02 g  in 1 g
EDETATE DISODIUM (UNII: 7FLD91C86K) 0.001 g  in 1 g
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73557-139-055 in 1 BOX11/22/202112/30/2022
1NDC: 73557-139-013 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 finalpart34811/22/202112/30/2022
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(73557-139) , label(73557-139)

Revised: 12/2022
 
Shanghai Chuang

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