BURN RELIEF PROFESSIONAL BIO-KOOL- lidocaine - 4% cream 
Kool-Down Inc.

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Drug Facts

Lidocaine - 4.0%

Topical Pain Reliever

Uses

Temporarily relieves pain due to: sunburns, burns, insect bites, and itching.

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

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

Aloe Barbadensis Leaf Juice, Glycerol, 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, Fragrance.

labelimage description

BURN RELIEF PROFESSIONAL  BIO-KOOL
lidocaine - 4% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61566-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61566-201-04113 g in 1 BOTTLE; Type 0: Not a Combination Product01/15/2013
2NDC:61566-201-14128 g in 1 JAR; Type 0: Not a Combination Product06/23/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/15/2013
Labeler - Kool-Down Inc. (146580548)
Registrant - Derma Care Research Labs (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derrma Care Research Labs116817470manufacture(61566-201)

Revised: 6/2025
Document Id: 3893cf5b-7ca1-321b-e063-6294a90a9cb5
Set id: 827e9c69-4706-0ccf-e053-2991aa0aa1c1
Version: 3
Effective Time: 20250627
 
Kool-Down Inc.