Myderm Pro Freeze Cooling Menthol Pain Relief Roll-on (is0252)

Myderm Pro Freeze Cooling Menthol Pain Relief Roll-on (is0252)
SPL v2
SPL
SPL Set ID 12ff9b9a-73e5-ce31-e063-6294a90aeaf8
Route
TOPICAL
Published
Effective Date 2024-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-06

Description

Active Ingredient Menthol 6%


Medication Information

Warnings and Precautions

For external use only.

Dosage and Administration

Direction: Apply to affectered area not more that 3 to 4 times daily.

Description

Active Ingredient Menthol 6%

Section 50565-1

keep out of reach of children if swallowed,get medical help or contact a poson Control Center Immediately.

Section 50566-9

Stop use and ask doctor if condition worsens, or if symtoms persist for more than 7 days, or clean up and reoccur again within a few days.

Section 50567-7

When using this product avoid contacts with the eyes or mucous membranes. do not apply to wounds or damaged skin. do not apply to irritated skin. do not bandage. wash hands after use with cool water. do not use with heating pad or device.

Section 51727-6

Inactive Ingredient

Aloe Barbadensis Leaf Juice

Arctium Lappa Root 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

Glycerin

Isopropyl Alcohol

Isopropyl Myristate

llex Paraguariensis Leaf Extract

Melissa Officinalis Leaf Extract

Phenoxyethanol

Silicon dioxide

Tocopheryl Acetate

Triethanolamine

Water

Section 51945-4

Section 55105-1

Menthol 6%------------------------------------------------------------Topical Analgesic

Section 55106-9

Active Ingredient

Menthol 6%


Structured Label Content

Dosage and Administration (34068-7)

Direction: Apply to affectered area not more that 3 to 4 times daily.

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 poson Control Center Immediately.

Section 50566-9 (50566-9)

Stop use and ask doctor if condition worsens, or if symtoms persist for more than 7 days, or clean up and reoccur again within a few days.

Section 50567-7 (50567-7)

When using this product avoid contacts with the eyes or mucous membranes. do not apply to wounds or damaged skin. do not apply to irritated skin. do not bandage. wash hands after use with cool water. do not use with heating pad or device.

Section 51727-6 (51727-6)

Inactive Ingredient

Aloe Barbadensis Leaf Juice

Arctium Lappa Root 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

Glycerin

Isopropyl Alcohol

Isopropyl Myristate

llex Paraguariensis Leaf Extract

Melissa Officinalis Leaf Extract

Phenoxyethanol

Silicon dioxide

Tocopheryl Acetate

Triethanolamine

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Menthol 6%------------------------------------------------------------Topical Analgesic

Section 55106-9 (55106-9)

Active Ingredient

Menthol 6%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)