OVERNIGHT RELIEF GEL-PATCH- menthol patch

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]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OVERNIGHT RELIEF GEL-PATCH 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73557-133
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
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 K90 (UNII: RDH86HJV5Z)	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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73557-133-05	5 in 1 BOX	12/30/2022
1	NDC: 73557-133-01	8 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 73557-133-04	4 in 1 BOX	12/27/2024
2		8 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 Drug	M017	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(73557-133) , label(73557-133)