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

Keep Out of Reach of Children

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

Uses

Temporarily relieves pain due to:

burns
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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61566-117
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	3.9 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61566-117-04	113 g in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/15/2013

Labeler - Kool-Down Inc (146580548)

Registrant - CGI Packaging, LLC (080691099)

Name	Address	ID/FEI	Business Operations
Establishment
CGI Packaging, LLC		080691099	manufacture(61566-117)