SPL v2
SPL
SPL Set ID 1cbc566e-61f4-e3d8-e063-6394a90a3144
Route
CUTANEOUS
Published
Effective Date 2024-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Peppermint (2 g)
Inactive Ingredients
Water Phenoxyethanol Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-24

Description

water Glycerin Gel base Phenoxyethanol

Purpose

QULCK ACTING NO REFRIGERATION NEEDED LONG-LASTING


Medication Information

Purpose

QULCK ACTING

NO REFRIGERATION NEEDED

LONG-LASTING

Description

water Glycerin Gel base Phenoxyethanol

When

When use on children,adulit,su-pervisionis required*When body tempera-ture over 39c seek medical advice

Dosage

1pc one time

Section 51945-4

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

Storage

Storage: Store at room temperature andaway from sunlight and out of children

Warning

Caution:

Use only as directed for extemal use *Avoiddirect contact with eyes &nostres*;Discontintue useifrashes,redness.itechigerirritation occurs&contact yourdoctor*; When use on children,adulit,su-pervisionis required*When body tempera-ture over 39c seek medical advice

Inactive

water

Glycerin

Gel base

Phenoxyethanol

How to Use

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

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


Structured Label Content

When (when)

When use on children,adulit,su-pervisionis required*When body tempera-ture over 39c seek medical advice

Dosage

1pc one time

Section 51945-4 (51945-4)

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

Purpose

QULCK ACTING

NO REFRIGERATION NEEDED

LONG-LASTING

Storage

Storage: Store at room temperature andaway from sunlight and out of children

Warning

Caution:

Use only as directed for extemal use *Avoiddirect contact with eyes &nostres*;Discontintue useifrashes,redness.itechigerirritation occurs&contact yourdoctor*; When use on children,adulit,su-pervisionis required*When body tempera-ture over 39c seek medical advice

Inactive

water

Glycerin

Gel base

Phenoxyethanol

How to Use (how to use)

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

Inforamtion (inforamtion)

Avoiddirect contact with eyes &nostres*,Discontintue useifrashes,redness.itechiger irritation occurs&contact your doctor

Stop to Use (stop to use)

Avoiddirect contact with eyes &nostres*,Discontintue useifrashes,redness.itechiger irritation occurs&contact your doctor


Advanced Ingredient Data


Raw Label Data

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