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

CVS Health Cold and Hot Roll-On by

Drug Labeling and Warnings

CVS Health Cold and Hot Roll-On by is a Otc medication manufactured, distributed, or labeled by NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Lidocaine 4%

Menthol 1%

Purpose

Topical anesthetic

Topical analgesic

Uses

temporarily relieves minor pain

Warnings

For external use only

• Avoid contact with eyes or mucous membranes
• Do not apply to open wounds or damaged skin
• Do not bandage or use heating pad

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

• for adults and children 12 or over
• under 12 consult doctor before use

Other information

• This product may cause allergic reaction in some individuals. Test on small area before use.

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, Ethylhexylgycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Methylparaben, SDA 40-2 Alcohol, Steareth-21

Principal Display Panel - 73.9 mL Box Label

CVS
Health™

Compare to active ingredients in IcyHot® Lidocaine Plus Menthol*

MAXIMUM STRENGTH

Cold & Hot

Roll-On

LIDOCAINE HCl 4%

MENTHOL 1%

• Safe & effective
• Fast acting & long lasting
• Desensitizes aggravated nerves

Actual Bottle Size on Side Panel

NET WT

2.5 FL OZ (73.9 mL)

Principal Display Panel - 73.9 mL Container Label

CVS
Health™

Compare to active ingredients in IcyHot® Lidocaine Plus Menthol*

MAXIMUM STRENGTH

Cold & Hot

Roll-On

LIDOCAINE HCl 4%

MENTHOL 1%

• Safe & effective
• Fast acting & long lasting
• Desensitizes aggravated nerves

NET WT 2.5 FL OZ (73.9 mL)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-156
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-156-25	1 in 1 BOX	09/14/2018
1		73.9 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/14/2018

Labeler - NATURAL ESSENTIALS, INC. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS, INC.		947484713	MANUFACTURE(66902-156)