Burn Relief Professional by Kool-Down Inc. / Product Quest Mfg Drug Facts

Burn Relief Professional by

Drug Labeling and Warnings

Burn Relief Professional by is a Otc medication manufactured, distributed, or labeled by Kool-Down Inc., Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BURN RELIEF PROFESSIONAL KOOL-DOWN- lidocaine - 4% 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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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

image description

BURN RELIEF PROFESSIONAL  KOOL-DOWN
lidocaine - 4% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61566-105
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)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
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: 61566-105-04113 g in 1 BOTTLE; Type 0: Not a Combination Product01/15/201302/05/2020
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/FEIBusiness Operations
Product Quest Mfg927768135manufacture(61566-105) , label(61566-105)

Revised: 12/2017
 

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