Qc Cool & Heat Roll-on

Qc Cool & Heat Roll-on
SPL v3
SPL
SPL Set ID d35e9dfa-8a28-fdb3-e053-2995a90abc52
Route
TOPICAL
Published
Effective Date 2021-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (16 g)
Inactive Ingredients
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Xanthan Gum Propylene Glycol Alcohol Phenoxyethanol Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-16
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, do not apply to wounds or damaged skin, and 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 pain associated with arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

Dosage and Administration

Clean affected area before applying product. 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 old 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

Acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., glycerin, phenoxyethanol, propylene glycol, water, xanthan gum.

Section 51945-4

Section 55105-1



External Analgesic

Section 55106-9

Menthol 16%

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Clean affected area before applying product. 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 old 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, do not apply to wounds or damaged skin, and 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 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., glycerin, phenoxyethanol, propylene glycol, water, xanthan gum.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)



External Analgesic

Section 55106-9 (55106-9)

Menthol 16%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:50.565741 · Updated: 2026-03-14T23:05:54.616139