ISHANCARE PAIN RELIEF GEL-PATCH- menthol patch

iShanCare PAIN RELIEF Gel-Patch by

Drug Labeling and Warnings

iShanCare PAIN RELIEF Gel-Patch by is a Homeopathic medication manufactured, distributed, or labeled by Shenzhen Ishan Technology Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Inactive Ingredients

Water, Dihydroxyaluminum Aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate80 Povidone K90 Propylene Glycol, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide.

Active ingredients

Active ingredients Purpose Lidocaine 4%---Topical anesthetic

Menthol 1%---Topical anesthetic

Keep out of reach of children

if swallowed, call poison control or seek medical help.

Ask a doctor

before using on children under 2 years of age.

Stop use

Stop use and ask a doctor if ● symptoms persist for more than 7 days
● conditions worsen.
● symptoms clear up and occur again within a few days. ● localized skin reactions, such as rash, itching, rednesspain, swelling and blistering develop.

Uses

For temporary relief of pain.

Other information

Store in a clean, dry place outside of direct sunlight. Protect productfrom excessive moisture.

Directions

Adults and children 12 years of age and over: ● clean and dry affected area.
● apply 1 patch at a time to affected area, not morethan 3 to 4 times daily. ● remove film from patch and apply to the skin. Children under 12 years of age: consult a doctor

When using this product

When using this product * use only as directed.

* do not bandage tightly.
* avoid contact with the eyes, mucous membranes or rashes.

Warnings

Warnings
For external use only
Do not use
* more than 1 patch at a time.
* on wounds, damaged skin or with a heating pad.
* if you are allergic to any ingredients of this product.

Dosage and administration

Lable

INGREDIENTS AND APPEARANCE

ISHANCARE PAIN RELIEF GEL-PATCH 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73076-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TARTARIC ACID (UNII: W4888I119H)
GLYCERIN (UNII: PDC6A3C0OX)
POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J)
POVIDONE K90 (UNII: RDH86HJV5Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73076-300-01	4 in 1 BOX	12/01/2024
1		12 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 73076-300-02	8 in 1 BOX	12/01/2024
2		12 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
unapproved homeopathic		12/01/2024

Labeler - Shenzhen Ishan Technology Co., Ltd (554484192)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Ishan Technology Co., Ltd		554484192	manufacture(73076-300)