Burn Relief Extra Strength Kool-Down (Lidocaine - 3.9%) Cream [Kool-Down Inc] -

BURN RELIEF EXTRA STRENGTH KOOL-DOWN (LIDOCAINE - 3.9%) CREAM [KOOL-DOWN INC]
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NDC	61566-279-04
Set ID	827fec2f-db3c-adbb-e053-2a91aa0a7c17
Category	HUMAN OTC DRUG LABEL
Packager	Kool-Down Inc
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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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

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:61566-279-04	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 - Derma Care Research Labs (116817470)

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

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