Myderm Cooling Menthol Pain Relief Spray With 50% More Menthol

Myderm Cooling Menthol Pain Relief Spray With 50% More Menthol
SPL v5
SPL
SPL Set ID d4276749-eeff-28f7-e053-2a95a90a593d
Route
TOPICAL
Published
Effective Date 2021-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (15.75 g)
Inactive Ingredients
Frankincense Fd&c Yellow No. 5 Glycerin Melissa Officinalis Leaf Trolamine Water Aloe Vera Leaf Arctium Lappa Root Arnica Montana Flower Isopropyl Myristate Ilex Paraguariensis Leaf Calendula Officinalis Flower Green Tea Leaf Camphor (natural) Carbomer 940 Fd&c Blue No. 1 Isopropyl Alcohol Silicon Dioxide .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-27

Description

Active ingredient Menthol 10.5%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Uses Temporary relief from minor aches and pains of muscles and joints associated with, arthritis, simple backache, strains, bruises, sprains.

Dosage and Administration

Adults and children 2 years of age and older: Apply to affected area no more than 3 to 4 times daily. Wash hands with soap. Children under 2 years of age: consult a doctor.

Description

Active ingredient Menthol 10.5%

Section 50565-1

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if, condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50567-7

When using this product, avoid contact with eyes and mucous membranes., do not apply to wound or damage skin, do not bandage, do not use with heating pad or device.

Section 51727-6

INACTIVE INGREDIENTS

Aloe Barbadensis Leaf Extract

Arctium Lappa Root (Burdock) Extract

Arnica Montana Flower Extract

Boswellia Carterii Resin Extract

Calendula Officinalis Extract

Camellia Sinensis Leaf Extract

Camphor

Carbomer

FD&C Blue #1

FD&C Yellow #5

Full Spectrum Industrial Hemp Extract

Glycerin

Ilex Paraguariensis (Mate) Leaf Extract

Isopropyl Alcohol

Isopropyl Myristate

Melissa Officinalis (Lemon Balm) Leaf Extract

Silica

Tocopheryl Acetate

Triethanolamine

Water

Section 51945-4

Section 55105-1

Menthol 10.4% ................. Topical Analgesic

Section 55106-9

Active ingredient

Menthol 10.5%


Structured Label Content

Indications and Usage (34067-9)

Uses Temporary relief from minor aches and pains of muscles and joints associated with, arthritis, simple backache, strains, bruises, sprains.

Dosage and Administration (34068-7)

Adults and children 2 years of age and older: Apply to affected area no more than 3 to 4 times daily. Wash hands with soap. Children under 2 years of age: consult a doctor.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if, condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50567-7 (50567-7)

When using this product, avoid contact with eyes and mucous membranes., do not apply to wound or damage skin, do not bandage, do not use with heating pad or device.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS

Aloe Barbadensis Leaf Extract

Arctium Lappa Root (Burdock) Extract

Arnica Montana Flower Extract

Boswellia Carterii Resin Extract

Calendula Officinalis Extract

Camellia Sinensis Leaf Extract

Camphor

Carbomer

FD&C Blue #1

FD&C Yellow #5

Full Spectrum Industrial Hemp Extract

Glycerin

Ilex Paraguariensis (Mate) Leaf Extract

Isopropyl Alcohol

Isopropyl Myristate

Melissa Officinalis (Lemon Balm) Leaf Extract

Silica

Tocopheryl Acetate

Triethanolamine

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Menthol 10.4% ................. Topical Analgesic

Section 55106-9 (55106-9)

Active ingredient

Menthol 10.5%


Advanced Ingredient Data


Raw Label Data

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