MENTHOL PAIN RELIEF GEL-PATCH- menthol patch

MENTHOL PAIN RELIEF Gel-Patch by

Drug Labeling and Warnings

MENTHOL PAIN 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 5.0%

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

Ask a doctor before use if you have:

Sensitive skin

When using this product:

·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 ·Store in a cool dry place away from direct sunlight

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

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

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L-Tartaric Acid, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Titanium dioxide, Water

Questions or Comments:

1 646-223-0128 ·Lu.FDAmanage@gmail.com

STORAGE AND HANDLING

·Store in a cool dry place away from direct sunlight

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MENTHOL PAIN RELIEF GEL-PATCH 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73557-131
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
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FRANKINCENSE (UNII: R9XLF1R1WM)
KAOLIN (UNII: 24H4NWX5CO)
TARTARIC ACID (UNII: W4888I119H)
WATER (UNII: 059QF0KO0R)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE K90 (UNII: RDH86HJV5Z)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73557-131-15	15 in 1 BOX	01/09/2024	01/16/2024
1	NDC: 73557-131-01	13 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 73557-131-16	15 in 1 BOX	01/09/2024
2	NDC: 73557-131-02	11 g in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 73557-131-05	5 in 1 BOX	02/02/2024
3	NDC: 73557-131-02	11 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	01/09/2024

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(73557-131) , label(73557-131)