BURN RELIEF EXTRA STRENGTH KOOL-DOWN- lidocaine - 3.9% cream 
Kool-Down 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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Active ingredient

Lidocaine - 3.9%


Purpose

Topical Pain Reliever

Uses

Temporarily relieves pain due to:

Warnings

For external use only.

Do not use in large quantities, particularity over raw surfaces or blistered areas.

When using this product keep out of eyes, use only as directed.

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

Keep Out of Reach of Children

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

Directions

Adults and children 5 years of age and older: apply to affected area not more that 3-4 times daily. Children under 5 years of age: ask a doctor.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Glycerin, Stearic Acid, Glyceryl Stearate SE, Isopropyl Myristate, Ethoxydiglycol, Ozokerite, Polysorbate 80, Carbomer, Zinc Oxide, Allantoin, Ascorbic Acid, Methylparaben, Diazolidinyl Urea, Propylparaben, Triethanolamine, Tetrasodium EDTA, Tocopheryl Acetate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Canola Oil, Fragrance.

image description

BURN RELIEF EXTRA STRENGTH  KOOL-DOWN
lidocaine - 3.9% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61566-279
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE3.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
CERESIN (UNII: Q1LS2UJO3A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALMOND OIL (UNII: 66YXD4DKO9)  
CANOLA OIL (UNII: 331KBJ17RK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61566-279-04113 g in 1 BOTTLE; Type 0: Not a Combination Product04/15/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/15/2013
Labeler - Kool-Down Inc (146580548)
Registrant - Derma Care Research Labs (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs116817470manufacture(61566-279)

Revised: 2/2019
Document Id: 8281047f-2f91-ea48-e053-2991aa0a0f9d
Set id: 827fec2f-db3c-adbb-e053-2a91aa0a7c17
Version: 2
Effective Time: 20190222
 
Kool-Down Inc