MedPath
FDA Approval

iShanCare

May 27, 2025

HUMAN OTC DRUG LABEL

MINT-5(0.5 g in 100 g)

Manufacturing Establishments (1)

Shenzhen Ishan Technology Co., Ltd

Shenzhen Ishan Technology Co., Ltd

554484192

Products (1)

iShanCare

73076-180

TOPICAL

May 27, 2025

CARBOMER 940Inactive
Code: 4Q93RCW27EClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
DIATOMACEOUS EARTHInactive
Code: 2RF6EJ0M85Class: IACT
MINT-5Active
Code: FV98Z8GITPClass: ACTIBQuantity: 0.5 g in 100 g

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lable

cooling patch


RECENT MAJOR CHANGES SECTION


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.

DOSAGE & ADMINISTRATION SECTION

Dosage & administration

Apply as needed, do not re-use.


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.

USER SAFETY WARNINGS SECTION

When using this product

Do not wear this product directly on skin.

Be aware of low-temperature burns.


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.


OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Mint Extract 0.5%

OTC - PURPOSE SECTION

USES

Temporarily relieves from fever discomfort, headache, toothache, muscle ache, jointsoreness, drowsiness, fatigue and sunstroke.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor if

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

if swallowed, call poison control or seek medical help.

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.


INACTIVE INGREDIENT SECTION

Inactive ingredient

Water, Carbomer, Crospovidone,Edetate Disodium Anhydrous, Povidone.FD&C Blue No.1,CarboxymethylcelluloseSodium,Sodium Benzoate, Diatomaceous Earth.


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