Dch Cool And Heat Spray, 16% Menthol

Dch Cool And Heat Spray, 16% Menthol
SPL v2
SPL
SPL Set ID ff323282-612c-eaf8-e053-6394a90ab779
Route
TOPICAL
Published
Effective Date 2021-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (16 g)
Inactive Ingredients
Propylene Glycol Water Glycerin Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-12

Description

Menthol 16%


Medication Information

Warnings and Precautions

For external use only. Flammable--Keep away from fire or flame. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water, do not apply to wounds or damaged skin, and do not bandage tightly, do not use with a heating pad. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . 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, bruises, and sprains.

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 16%

Section 50565-1

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

Section 51727-6

Alcohol Denat., Glycerin, Propylene Glycol, Water

Section 51945-4

Section 55105-1



Topical Analgesic

Section 55106-9

Menthol 16%


Structured Label Content

Indications and Usage (34067-9)

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

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. Flammable--Keep away from fire or flame. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water, do not apply to wounds or damaged skin, and do not bandage tightly, do not use with a heating pad. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . 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 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Alcohol Denat., Glycerin, Propylene Glycol, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)



Topical Analgesic

Section 55106-9 (55106-9)

Menthol 16%


Advanced Ingredient Data


Raw Label Data

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