Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID e82f99fd-c2ef-686f-e053-2a95a90a1dc9
Route
TOPICAL
Published
Effective Date 2022-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.5 g)
Inactive Ingredients
Pyridoxine Hydrochloride Citric Acid Monohydrate Sodium Benzoate Diacetylated Monoglycerides Glycerin Cannabis Sativa Seed Oil Arnica Montana Flower Cetostearyl Alcohol Polyoxyl 20 Cetostearyl Ether Peg-100 Stearate Sunflower Oil Shea Butter Cetyl Esters Wax Glyceryl Monostearate Water Peppermint Oil Phenoxyethanol Potassium Sorbate Tocopherol .beta.-sitosterol Diethylene Glycol Monoethyl Ether Dimethyl Sulfone Glucosamine Hydrochloride Ethylhexylglycerin Ammonium Acryloyldimethyltaurate/vp Copolymer Aloe Vera Leaf Dimethicone Glycyrrhizinate Dipotassium Squalene Linalool, (+/-)- Frankincense Oil Limonene, (+)- Methyl Gluceth-20 Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-08

Description

Active ingredient Menthol 1.5%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

simple backache

arthritis

strains

bruises

sprains

Dosage and Administration

Directions

Adults and children 2 years of age and olden Apply to affected area not more than 3 to 4 times daily Children under 2 years of age: ask a doctor

Description

Active ingredient Menthol 1.5%

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

irritation occurs

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

do not bandage tightly

Section 50570-1

Do not use

on wounds or damaged skin

Section 51727-6

Inactive Ingredients

Water, Glycerin,Cannabis Sativa Seed Oil, Arnica Montana Flower Extract, Glyceryl Stearates, Cetearyl Alcohol,Ceteareth-20,

PEG-100 Stearate,Butyrospermum Parkii (Shea) Butter, Cetyl Esters,Ammonium Acryloyldimethyltaurate/VP Copolymer,

Aloe Barbadensis Leaf Juice, Ethoxydiglycol, Dimethicone, Dipotassium Glycyrrhizate,Dimethyl Sulfone, Sodium Phytate,

Pyridoxine HCI, Methyl Gluceth-20, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Boswellia Carterii Oil,Menthe Piperita (Peppermint) Oil,Glucosamine HCI, Citric Acid, Phenoxyethanol,Potassium Sorbate,Sodium Benzoate, Ethylhexylglycerin,Tocopherol,

Monoglycerides,Sunflower Oil,Beta-Sitosterol, Squalene,Limonene, Linalool.

Section 51945-4

Section 55105-1

Purpose

Topical analgesic

Section 55106-9

Active ingredient

Menthol 1.5%

Section 60561-8

Other Information

Store in a cool, dry place away from light

If pregnant or breast-feeding, ask a health professional before use


Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

simple backache

arthritis

strains

bruises

sprains

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and olden Apply to affected area not more than 3 to 4 times daily Children under 2 years of age: ask a doctor

Warnings and Precautions (34071-1)

Warnings

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

irritation occurs

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

do not bandage tightly

Section 50570-1 (50570-1)

Do not use

on wounds or damaged skin

Section 51727-6 (51727-6)

Inactive Ingredients

Water, Glycerin,Cannabis Sativa Seed Oil, Arnica Montana Flower Extract, Glyceryl Stearates, Cetearyl Alcohol,Ceteareth-20,

PEG-100 Stearate,Butyrospermum Parkii (Shea) Butter, Cetyl Esters,Ammonium Acryloyldimethyltaurate/VP Copolymer,

Aloe Barbadensis Leaf Juice, Ethoxydiglycol, Dimethicone, Dipotassium Glycyrrhizate,Dimethyl Sulfone, Sodium Phytate,

Pyridoxine HCI, Methyl Gluceth-20, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Boswellia Carterii Oil,Menthe Piperita (Peppermint) Oil,Glucosamine HCI, Citric Acid, Phenoxyethanol,Potassium Sorbate,Sodium Benzoate, Ethylhexylglycerin,Tocopherol,

Monoglycerides,Sunflower Oil,Beta-Sitosterol, Squalene,Limonene, Linalool.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Topical analgesic

Section 55106-9 (55106-9)

Active ingredient

Menthol 1.5%

Section 60561-8 (60561-8)

Other Information

Store in a cool, dry place away from light

If pregnant or breast-feeding, ask a health professional before use


Advanced Ingredient Data


Raw Label Data

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