dch labs cool & heat roll-on

dch labs cool & heat roll-on
SPL v2
SPL
SPL Set ID d35d7720-44ce-3624-e053-2995a90a7fb4
Route
topical
Published
Effective Date 2021-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (16 g)
Inactive Ingredients
propylene glycol alcohol phenoxyethanol water glycerin carbomer interpolymer type a (allyl sucrose crosslinked) xanthan gum

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.

Active Ingredient

Menthol 16%

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

Structured Label Content

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.

Active Ingredient (55106-9)

Menthol 16%

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.

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:59.317804 · Updated: 2026-03-14T23:06:15.168093