QC Cool and Heat Roll-On

Manufacturer: Chain Drug Marketing Association Inc | Derma Care Research Labs, LLC
Effective date: 2024-12-15
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 00:43:46

Label at a glance#

ProductQC Cool and Heat Roll-On

Active ingredientMENTHOL

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 16%

OTC - PURPOSE SECTION

External Analgesic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
866084	menthol 16 % Topical Solution	PSN	3
866084	menthol 160 MG/ML Topical Solution	SCD	3
866084	menthol 16 % Topical Solution	SY	3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-511-02	QC Cool and Heat Roll-On	71 g in 1 BOTTLE	LIQUID	71		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-511	QC COOL AND HEAT ROLL-ON (MENTHOL 16%) LIQUID [CHAIN DRUG MARKETING ASSOCIATION INC]	3	Current NDC, Legacy NDC, 1 package rows	20241217_d35e9dfa-8a28-fdb3-e053-2995a90abc52.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

QC Cool and Heat Roll-On
Menthol 16%
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
XANTHAN GUM
PROPYLENE GLYCOL
ALCOHOL
PHENOXYETHANOL
WATER
MENTHOL
GLYCERIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63868-511	63868-511-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	59TL3WG5CO	IACT
XANTHAN GUM	TTV12P4NEE	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
ALCOHOL	3K9958V90M	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
WATER	059QF0KO0R	IACT
MENTHOL	L7T10EIP3A	ACTIB
GLYCERIN	PDC6A3C0OX	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QC Cool and Heat Roll-On	MENTHOL 16%	Chain Drug Marketing Association Inc	d35e9dfa-8a28-fdb3-e053-2995a90abc52	2024-12-15	Warnings	Exact identifier ndc (package): 63868-511-02 ndc (product): 63868-511 ndc11 (package): 63868051102 spl id: 295792be-d777-7ef8-e063-6294a90a1e44 spl set id: d35e9dfa-8a28-fdb3-e053-2995a90abc52

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.