Flexigen, Menthol 1.25%

Flexigen, Menthol 1.25%
SPL v2
SPL
SPL Set ID e9ae2682-59b4-e796-e053-2995a90af921
Route
TOPICAL
Published
Effective Date 2022-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.25 g)
Inactive Ingredients
Frankincense Oil Shea Butter Glyceryl Stearate Se Aloe Vera Leaf Lavender Oil Carboxymethylcellulose Sodium Rice Bran Ethylhexylglycerin Cetostearyl Alcohol Cetyl Alcohol Water Xanthan Gum Glycerin Calendula Officinalis Flower Chamomile Tocopherol Green Tea Leaf Phenoxyethanol Polysorbate 60 Medium-chain Triglycerides Sesame Oil Stearyl Alcohol Citric Acid Monohydrate Orange Peel Coconut Oil Dimethicone 200 Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-11

Description

Menthol 1.25%


Medication Information

Warnings and Precautions

For external use only. Do not use with other topical pain relievers, with heating pads or heating devices. When using this product do not use in or near the eyes, do not apply to wounds or damaged skin, do not bandage tightly. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

Indications and Usage

For the temporary relief of minor aches and pain associated with arthritis, simple backache, muscle strains, sprains, and bruises.

Dosage and Administration

Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Description

Menthol 1.25%

Section 42228-7

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

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Aloe Barbadensis Leaf Extract, Boswellia Carterii Oil, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Citrus Sinensis (Orange) Peel Oil, Cocos Nucifera (Coconut) Oil, Dimethicone, Disodium EDTA, Ethylhexylglyerin, Glycerin, Glyceryl Stearate SE, Hydrolyzed Rice Protein, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polysorbate 60, Sesamum Indicum (Sesame) Seed Oil, Stearyl Alcohol, Tocopherol, Water, Xanthan Gum.

Section 51945-4

Section 55105-1



Pain Relieving Cream

Section 55106-9

Menthol 1.25%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pain associated with arthritis, simple backache, muscle strains, sprains, and bruises.

Dosage and Administration (34068-7)

Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Warnings and Precautions (34071-1)

For external use only. Do not use with other topical pain relievers, with heating pads or heating devices. When using this product do not use in or near the eyes, do not apply to wounds or damaged skin, do not bandage tightly. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 42228-7 (42228-7)

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

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Aloe Barbadensis Leaf Extract, Boswellia Carterii Oil, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Citrus Sinensis (Orange) Peel Oil, Cocos Nucifera (Coconut) Oil, Dimethicone, Disodium EDTA, Ethylhexylglyerin, Glycerin, Glyceryl Stearate SE, Hydrolyzed Rice Protein, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polysorbate 60, Sesamum Indicum (Sesame) Seed Oil, Stearyl Alcohol, Tocopherol, Water, Xanthan Gum.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)



Pain Relieving Cream

Section 55106-9 (55106-9)

Menthol 1.25%


Advanced Ingredient Data


Raw Label Data

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