QC Cool & Heat Roll-On

QC Cool and Heat Roll-On by

Drug Labeling and Warnings

QC Cool and Heat Roll-On by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association Inc, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

QC COOL AND HEAT ROLL-ON- lidocaine hcl 0.5% liquid 
Chain Drug Marketing Association Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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QC Cool & Heat Roll-On

Lidocaine HCl 0.5%

External Analgesic

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

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.

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

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.

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

QC COOL AND HEAT ROLL-ON 
lidocaine hcl 0.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-105-02	71 g in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/16/2021	12/16/2021

Labeler - Chain Drug Marketing Association Inc (011920774)

Registrant - Derma Care Research Labs, LLC (116817470)

Revised: 12/2021

Document Id: d35ec989-dc03-5dd8-e053-2995a90a3e0d

34390-5

Set id: d34a2471-4d1f-29b9-e053-2a95a90a29bd

Version: 2

Effective Time: 20211217