Myderm Cooling Menthol Pain Relief Gel With 50% More Menthol

Myderm Cooling Menthol Pain Relief Gel With 50% More Menthol
SPL v12
SPL
SPL Set ID d427d623-c2fd-7d6b-e053-2995a90abdc3
Route
TOPICAL
Published
Effective Date 2021-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (6 g)
Inactive Ingredients
Isopropyl Myristate Calendula Officinalis Flower Fd&c Yellow No. 5 Silicon Dioxide Arctium Lappa Root Camphor (natural) Melissa Officinalis Leaf .alpha.-tocopherol Acetate Green Tea Leaf Water Ilex Paraguariensis Leaf Isopropyl Alcohol Carbomer 940 Aloe Vera Leaf Trolamine Arnica Montana Flower Frankincense Fd&c Blue No. 1 Glycerin

Identifiers & Packaging

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

Description

Active ingredient Menthol 4%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Uses Temporary relief of pain

Dosage and Administration

Directions

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 4%

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 doctor if, condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50567-7

DO not use in large quantities over raw surfaces and blistered area

When using this product

Use only as directed, read and follow all directions and warnings on this label, rare cases of serious burn have been reported with product of this type, do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with medicated patch, avoid contact with eyes and mucous membranes

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 4% ........... Topical analgesic

Section 55106-9

Active ingredient

Menthol 4%


Structured Label Content

Indications and Usage (34067-9)

Uses Temporary relief of pain

Dosage and Administration (34068-7)

Directions

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 doctor if, condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50567-7 (50567-7)

DO not use in large quantities over raw surfaces and blistered area

When using this product

Use only as directed, read and follow all directions and warnings on this label, rare cases of serious burn have been reported with product of this type, do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with medicated patch, avoid contact with eyes and mucous membranes

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 4% ........... Topical analgesic

Section 55106-9 (55106-9)

Active ingredient

Menthol 4%


Advanced Ingredient Data


Raw Label Data

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