SPL v2
SPL
SPL Set ID 361b41f7-4dbb-3f35-e063-6294a90a7e9f
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mint (0.5 g)
Inactive Ingredients
Carbomer 940 Crospovidone Edetate Disodium Povidone Fd&c Blue No. 1 Carboxymethylcellulose Sodium Sodium Benzoate Water Diatomaceous Earth

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-01-01

Description

Mint Extract 0.5%


Medication Information

Description

Mint Extract 0.5%

Uses

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

Lable

Section 43683-2

no

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.

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.

Active Ingredient

Mint Extract 0.5%

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.

Inactive Ingredient

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

Dosage & Administration

Apply as needed, do not re-use.

When Using This Product

Do not wear this product directly on skin.

Be aware of low-temperature burns.

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.

Keep Out of Reach of Children.

if swallowed, call poison control or seek medical help.


Structured Label Content

Uses (USES)

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

Lable

Section 43683-2 (43683-2)

no

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.

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.

Active Ingredient (Active ingredient)

Mint Extract 0.5%

Other Information (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.

Inactive Ingredient (Inactive ingredient)

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

Dosage & Administration (Dosage & administration)

Apply as needed, do not re-use.

When Using This Product (When using this product)

Do not wear this product directly on skin.

Be aware of low-temperature burns.

Stop Use and Ask A Doctor If (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.

Keep Out of Reach of Children. (Keep out of reach of children.)

if swallowed, call poison control or seek medical help.


Advanced Ingredient Data


Raw Label Data

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