Cool and Heat by Evora Worldwide / Inspec Solution Drug Facts

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.

----------

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77375-006
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 77375-006-02	1 in 1 CARTON	06/15/2020
1		76.5 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/15/2020	12/31/2020

Labeler - Evora Worldwide (081336028)

Name	Address	ID/FEI	Business Operations
Establishment
Inspec Solution		081030372	manufacture(77375-006)

Revised: 12/2020

Document Id: b6c316c3-661d-6428-e053-2a95a90a1a6b

Set id: 31ddce70-0ce9-49bc-b719-15de101bf48c

Version: 2

Effective Time: 20201218