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SPL v1
SPL
SPL Set ID f163c9e7-39d0-3610-e053-2995a90a0990
Route
TOPICAL
Published
Effective Date 2023-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Menthol 8%


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

Menthol 8%

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: Abies Sibirica (Fir) Needle Oil Aloe barbadensis (Aloe Vera) Leaf Juice Beeswax Caprylyl Glycol Carthamus tinctorius (Safflower) seed oil Cetyl PEG/PPG-10/1 Dimethicone Chlorphenesin Cinnamomum camphora bark oil Eucalyptus globulus Leaf Oil Helianthus annuus (sunflower) seed oil Methyl salicylate PEG-40 Hydrogenated Castor Oil Phenoxyethanol Sodium Chloride Water

Section 51945-4

Sport IQ Pain Relief Cream 3.4 oz

Section 55105-1

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

Section 55106-9

Menthol 8%


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: Abies Sibirica (Fir) Needle Oil Aloe barbadensis (Aloe Vera) Leaf Juice Beeswax Caprylyl Glycol Carthamus tinctorius (Safflower) seed oil Cetyl PEG/PPG-10/1 Dimethicone Chlorphenesin Cinnamomum camphora bark oil Eucalyptus globulus Leaf Oil Helianthus annuus (sunflower) seed oil Methyl salicylate PEG-40 Hydrogenated Castor Oil Phenoxyethanol Sodium Chloride Water

Section 51945-4 (51945-4)

Sport IQ Pain Relief Cream 3.4 oz

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

Menthol 8%


Raw Label Data

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