MAXIMUM STRENGTH COLD AND HOT CVS- lidocaine hci 4% menthol 1% cream

Maximum Strength Cold and Hot by

Drug Labeling and Warnings

Maximum Strength Cold and Hot by is a Otc medication manufactured, distributed, or labeled by CVS, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                            Purpose

Lidocaine HCL 4%............................Topical analgesic

Menthol  1%.....................................Topical analgesic

PURPOSE

Uses

Temporarily relieves pain and itching due to:
sunburn minor burns minor cuts scrapes insect bites

WarningsFor external use only

Do not use in large quantities, particularly over raw surface or blistered areas

When using this product

avoid contact with eyes

do not apply to wounds or damages skin
do not bandage tightly or use with a heating pad
use only as directed

Stop use and ask a doctor if 
condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

adults and children 12 years of age and older: spray on affected area, not more than 3 to 4 times daily
children under 12 years of age: consult a doctor

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Aloe Barbadensis Leaf Extract
Aminomethyl Propanol
C30-45 Alkyl Cetearyl Dimethicone Crosspolymer
Caprylyl Methicone
Cetearyl Alcohol
Ceteth-20 Phosphate
Dicetyl Phosphate
Dimethicone
Disodium EDTA
Ethylhexylglycerin
Glyceryl Stearate SE
Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer
Isohexadecane
Methylparaben
Polysorbate 60
SD Alcohol 40
Steareth-21
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH COLD AND HOT  CVS
lidocaine hci 4% menthol 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-667
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 mL
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	Menthol	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
Ceteth-20 Phosphate (UNII: 921FTA1500)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
Dimethicone (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Ethylhexylglycerin (UNII: 147D247K3P)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
Isohexadecane (UNII: 918X1OUF1E)
Methylparaben (UNII: A2I8C7HI9T)
Polysorbate 60 (UNII: CAL22UVI4M)
ALCOHOL (UNII: 3K9958V90M)
Steareth-21 (UNII: 53J3F32P58)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-667-03	1 in 1 CARTON	01/30/2018
1		80 mL in 1 BOTTLE; 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	01/30/2018

Labeler - CVS (062312574)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(69842-667) , label(69842-667)