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Burn Relief Professional Kool-Down

Medically reviewed on December 20, 2017

Dosage form: cream
Ingredients: Lidocaine 4g in 100g
Labeler: Kool-Down Inc.
NDC Code: 61566-105

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 - 4.0%                    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:

  • sunburn
  • 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

Direction

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
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

BURN RELIEF PROFESSIONAL  KOOL-DOWN
lidocaine - 4% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61566-105
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine (LIDOCAINE) Lidocaine4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE 
GLYCERIN 
Stearic Acid 
Glyceryl Stearate SE 
Isopropyl Myristate 
DIETHYLENE GLYCOL MONOETHYL ETHER 
CERESIN 
Polysorbate 80 
CARBOMER 940 
Zinc Oxide 
Allantoin 
Ascorbic Acid 
Methylparaben 
DIAZOLIDINYL UREA 
Propylparaben 
TROLAMINE 
EDETATE SODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
ALMOND OIL 
Packaging
#Item CodePackage Description
1NDC:61566-105-04113 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/15/201302/05/2020
Labeler - Kool-Down Inc. (146580548)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIOperations
Product Quest Mfg927768135manufacture(61566-105), label(61566-105)

 
Kool-Down Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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