Cool and Heat by Evora Worldwide / Inspec Solution Drug Facts

Cool and Heat by

Drug Labeling and Warnings

Cool and Heat by is a Otc medication manufactured, distributed, or labeled by Evora Worldwide, Inspec Solution. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COOL AND HEAT EVORA LABS- lidocaine hcl , menthol cream 
Evora Worldwide

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                               Purpose

Lidocaine HCl 4%                                Topical analgesic

Menthol  1%                                         Topical analgesic

Uses

Temporarily relieves pain, itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites.

Warnings
For external use onle.

Do not use

  • in large quantities, particularly over raw surfaces or blistered areas
  • to wound or damaged, broken, or irritated skin

When using this product

  • use only as directed. Read and follow all directions and warnings on this label
  • rare cases of seriouse burns have been reported with products of this type
  • do not bandage tightly  or apply local heat (such as heating pads) to the area of use with medicated patch
  • avoid contact with eyes and mucous membranes

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more that 7 days or clear up and occur again within a few days

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children

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

Directions

Adultes and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age consult a doctor.

Inactive ingredients

Acrylates1c10-30 Alkyl Acrylate Crosspolymer, Aoe 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, lschexadecane, Methylparaben, Polysorbate 60,
SD Alcohol 40, Steareth-21, Water.

image description

COOL AND HEAT  EVORA LABS
lidocaine hcl , menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77375-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALOE (UNII: V5VD430YW9)  
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)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
ALCOHOL (UNII: 3K9958V90M)  
STEARETH-21 (UNII: 53J3F32P58)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77375-006-021 in 1 CARTON06/15/2020
176.5 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/15/202012/31/2020
Labeler - Evora Worldwide (081336028)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solution081030372manufacture(77375-006)

Revised: 12/2020
 

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