iShanCare
361b41f7-4dbb-3f35-e063-6294a90a7e9f
HUMAN OTC DRUG LABEL
May 27, 2025
Shenzhen Ishan Technology Co., Ltd
DUNS: 554484192
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mint extract
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Lable
INDICATIONS & USAGE SECTION
Directions
Clean and dry the skin
Pick out patch
Peel off film
Stick to skin
Note: lf desired, cut gel sheet to suitable sizewith scissors.
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Mint Extract 0.5%
INACTIVE INGREDIENT SECTION
Inactive ingredient
Water, Carbomer, Crospovidone,Edetate Disodium Anhydrous, Povidone.FD&C Blue No.1,CarboxymethylcelluloseSodium,Sodium Benzoate, Diatomaceous Earth.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
if swallowed, call poison control or seek medical help.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor if
OTC - STOP USE SECTION
Stop use and ask a doctor if
pain worsens or persists, or if youexperience any of these symptoms: burning, itching, rash, or other changes in theskin where the product was placed.
OTC - PURPOSE SECTION
USES
Temporarily relieves from fever discomfort, headache, toothache, muscle ache, jointsoreness, drowsiness, fatigue and sunstroke.
STORAGE AND HANDLING SECTION
Other information
Store in a cool place avoiding direct sunlightand high temperature. May even be stored inrefrigerator for extra cooling. Do not store infreezer.
For sanitary purposes, use each sheet onlyonce and discard after use.
DOSAGE & ADMINISTRATION SECTION
Dosage & administration
Apply as needed, do not re-use.
USER SAFETY WARNINGS SECTION
When using this product
Do not wear this product directly on skin.
Be aware of low-temperature burns.
WARNINGS SECTION
Warning
For external use only. Avoid direct contact witheyes.lf excessive redness, irritation, burning ordiscomfort of the skin develops, discontinueuse and consult a physician immediately. Donot apply to wounds or to irrtated, damaged,sunburned or very sensitve skin. The coolinggel sheet will not stick to skin if the skin is wetor if the gel sheet comes into contact with haireyebrows or clothing. Keep out of the reach ofchildren.Consult physician if fever persists orcondition worsens.