Active
EDETATE SODIUM 0.2%
Fever Cooling Patch
FDA Label NDC 84434-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhuhai Guojia International Trading Co., Ltd. for the product Fever Cooling Patch (NDC 84434-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active, inactive, purpose, warning, inforamtion, stop to use, when, storage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive
water
Glycerin
Gel base
Cooling Capsule
Purpose
NO REFRIGERATION NEEDED
QULCKACTING
LONG-LASTING
Warning
Caution:
Use only as directed for extemal use*Avoiddirect contact with eyes &nostres*;Discontintue useifrashes,redness.itechigerimritation
occurs&contact yourdoctor*; When use on children,adulit,su-pervisionis required*When body tempera-ture over 39c seek medical
advice
Inforamtion
Avoiddirect contact with eyes &nostres*,Discontintue useifrashes,redness.itechiger irritation occurs&contact your doctor
Stop To Use
Avoiddirect contact with eyes &nostres*,Discontintue useifrashes,redness.itechiger irritation occurs&contact your doctor
When
When use on children,adulit,su-pervisionis required*When body tempera-ture over 39c seek medical advice
Storage
Storage: Store at room temperature andaway from sunlight and out of children
How To Use
HOW TO USE:Cut or tear open pouch&remove coolinggel sheetremove transparent flm; Theback of the cooling gel sheet
&discardapply colling gel sheet surface; On theaffected area*The cooling gel sheet willnot stick if the skin is wet; For the bestresult use
each cooling gel sheet oniy once
HOW TO USE:Cut or tear open pouch&remove coolinggel sheet.remove transparent flm; Theback of the cooling gel sheet
&discardapply colling gel sheet surface; On theaffected area*The cooling gel sheet willnot stick if the skin is wet; For the bestresult use
each cooling gel sheet oniy once
Dosage
1pc one time
Package Label.Principal Display Panel
Description:The use of adult or child have a fever Absorbthe heat quickly reduce the heat quickly.
HOW TO USE:Cut or tear open pouch&remove coolinggelsheet.remove transparent flm;Theback of the cooling gel sheet
&discardapply colling gel sheet surface; On theaffected area*The cooling gel sheet willnot stick if the skin is wet; For the bestresult
use each cooling gel sheet oniy once
Caution:Use only as directed for extemal use*Avoiddirect contact with eyes
&nostres*;Discontintueuseifrashes,rednessitechigerirritation occurs&contact yourdoctor*; When use on children,adulit,su-pervision is
required*When body tempera-ture over 39c seek medical advice
Storage: Store at room temperature andaway from sunlight
* Please review the disclaimer below.
