CVS HEALTH COLD AND HOT ROLL-ON - lidocaine, menthol cream 
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 ingredients

Lidocaine HCl 4%

Menthol 1%

Purpose

Topical anesthetic

Topical analgesic

Uses

temporarily relieves minor pain

Warnings

For external use only

Do not use

  • on large areas of the body or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

Stop use and ask a doctor if

  • Condition worsens
  • servere skin irritation occurs
  • Symptoms persist for more than 7 days or clear up then reoccur again within a few days

Ask a doctor before use if you

  • Have sensitive skin
  • Are pregnant or breastfeeding

Keep out of reach of children.

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

Directions

Rub on affected area - repeat 3 to 4 times daily

Other information

Inactive ingredients

Acrylates/C10-30 Alkyl Crosspolymer, Aloe Vera Gel 10x, Aminomethyl Propanol, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Deionized Water, Dimethicone, Caprylyl Methicone, Polysilicone-11, Disodium EDTA, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Methylparaben, SDA 40-2 Alcohol, Steareth-21

Principal Display Panel – 73.9 mL Carton Label

CVS
Health
®

Compare to active
ingredients in IcyHot®
Lidocaine Plus Menthol*

MAXIMUM STRENGTH

Lidocaine concentration
without a prescription

Lidocaine
Pain Relief
Roll-On

PLUS MENTHOL

LIDOCAINE HCl 4%

MENTHOL 1%

Among over the counter
topical analgesics.

Actual Bottle Size
on Side Panel

2.5 FL OZ (73.9 mL)

Principal Display Panel – 73.9 mL Carton Label

Principal Display Panel – 73.9 mL Container Label

CVS
Health
®

MAXIMUM STRENGTH

Lidocaine concentration
without a prescription

Lidocaine
Pain Relief
Roll-On

PLUS MENTHOL

LIDOCAINE HCl 4%

MENTHOL 1%

2.5 FL OZ (73.9 mL)

Principal Display Panel – 73.9 mL Container Label
CVS HEALTH COLD AND HOT ROLL-ON  
lidocaine, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-156
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 41 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
ALCOHOL (UNII: 3K9958V90M)  
STEARETH-21 (UNII: 53J3F32P58)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66902-156-251 in 1 BOX09/14/2018
173.9 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 finalpart34809/14/2018
Labeler - NATURAL ESSENTIALS, INC. (947484713)
Establishment
NameAddressID/FEIBusiness Operations
NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-156)

Revised: 6/2023
Document Id: 3d9dc4f6-cfa2-4039-b3ae-97b735a0e4f0
Set id: 29ebc5dd-9d57-43b4-a7ce-4ea6d8b280cb
Version: 2
Effective Time: 20230601
 
NATURAL ESSENTIALS, INC.