BURN RELIEF- lidocaine - 3% menthol 1.0% lotion 
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.

----------

Drug Facts

Active ingredient Purpose

Lidocaine - 3.0% Topical paine reliever
Menthol - 1.0% Topical paine reliever

Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away
In case of accidental ingestion, seek professional or contact a Poison Control Center immediately.

Uses

Temporarily relieves pain due to:

burn
insect bites
itching

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
• symptoms last more than 7 days or clear up and occur again within a few days

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

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

image description

BURN RELIEF 
lidocaine - 3% menthol 1.0% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61566-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) Lidocaine3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Menthol (UNII: L7T10EIP3A) 1 g  in 100 g
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Glyceryl Stearate SE (UNII: FCZ5MH785I)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Alcohol (UNII: 3K9958V90M)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
CERESIN (UNII: Q1LS2UJO3A)  
Aloe (UNII: V5VD430YW9)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Allantoin (UNII: 344S277G0Z)  
PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
Canola Oil (UNII: 331KBJ17RK)  
Zinc Oxide (UNII: SOI2LOH54Z)  
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:61566-103-04113 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 finalpart34804/15/201302/05/2018
Labeler - Kool-Down Inc. (146580548)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(61566-103)

Revised: 12/2017
 
Kool-Down Inc.