BURN RELIEF EXTRA STRENGTH KOOL-DOWN- lidocaine - 3.9% cream

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient

Lidocaine - 3.9%

Purpose

Topical Pain Reliever

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

Keep Out of Reach of Children

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURN RELIEF EXTRA STRENGTH  KOOL-DOWN
lidocaine - 3.9% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61566-279
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61566-279-04	113 g in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2013

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

Labeler - Kool-Down Inc (146580548)

Registrant - Derma Care Research Labs (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs		116817470	manufacture(61566-279)