CVS HEALTH COLD AND HOT ROLL-ON  MENTHOL - menthol, unspecified form liquid 
NATURAL ESSENTIALS, 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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Drug Facts

Active ingredient:

Menthol 16%

Purpose:

Topical analgesic

Uses:

Warnings:

For external use only.

When using this product

  • use only as directed. Read and follow all directions and warnings on this label.
  • rare cases of serious burns have been reported with products of this type
  • do not bandage tightly or apply local heat (such as heating pads) or medicated patch to the area of use
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use immediately
  • do not expose the area treated with product to heat or direct sunlight
  • avoid applying into skin folds.

Stop use and ask a doctor if

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

Flammable

  • Keep away from fire or flame.

If pregnant or breast-feeding,

  • Ask a health professional before use.

Keep out of reach of children

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

Directions: adults and children over 12 years:

Children 12 years or younger

  • ask a doctor

Other information:

Store in a cool dry area. Close cap tightly after use.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Capsaicin, Deionized Water, Glycerin, Isopropyl Myristate, Propylene Glycol, SDA 40-2 Alcohol.

Principal Display Panel - Cold & Hot Roll-On Menthol 16% Box Label

CVS
Health™

Compare to the active
ingredient in Maximum
Strength IcyHot®
Pain Relieving Liquid

MAXIMUM STRENGTH

Cold & Hot
Roll-On

MENTHOL 16%

Pain-relieving liquid

Actual Product Size
on Side Panel

2.5 FL OZ (73 mL)

Principal Display Panel - Cold & Hot Roll-On Menthol 16% Box Label

Principal Display Panel - Cold & Hot Roll-On Menthol 16% Container Label

CVS
Health™

MAXIMUM STRENGTH

Cold & Hot
Roll-On

MENTHOL 16%

Pain-relieving liquid

2.5 FL OZ (73 mL)

Principal Display Panel - Cold & Hot Roll-On Menthol 16% Container Label
CVS HEALTH COLD AND HOT ROLL-ON   MENTHOL
menthol, unspecified form liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-241
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM160 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CAPSAICIN (UNII: S07O44R1ZM)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66902-241-251 in 1 BOX01/17/2018
173 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/17/2018
Labeler - NATURAL ESSENTIALS, INC. (947484713)
Establishment
NameAddressID/FEIBusiness Operations
NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-241)

Revised: 1/2019
Document Id: 0f5e4834-82dd-4f77-9c7d-853a693fce84
Set id: a94ff07f-3929-429a-9e77-e357b58de768
Version: 1
Effective Time: 20190117
 
NATURAL ESSENTIALS, INC.