BURN RELIEF KOL-DOWN- lidocaine - 3.0% menthol - 1.0% lotion
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 - 3.0% Topical paine reliever
Menthol - 1.0% 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:

burn
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

Water
Glycerin
Glyceryl Stearate SE
Stearic Acid
Isopropyl Myristate
Alcohol
Ethoxydiglycol
Ozokerite
Aloe Barbadensis Leaf Juice
Polysorbate 80
Allantoin
Passiflora Edulis Seed Oil
Gaultheria Procumbens (Wintergreen) Leaf Oil
Carbomer
Canola Oil
Zinc Oxide
Ascorbic Acid
Methylparaben
Diazolidinyl Urea
Propylparaben
Triethanolamine
Tetrasodium EDTA
Tocopheryl Acetate
Prunus Amygdalus Dulcis (Sweet Almond) Oil
Fragrance

image description

BURN RELIEF KOL-DOWN
lidocaine - 3.0% menthol - 1.0% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61566-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	Lidocaine	3 g in 100 mL
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	Menthol	1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Stearate SE (UNII: FCZ5MH785I)
Stearic Acid (UNII: 4ELV7Z65AP)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Alcohol (UNII: 3K9958V90M)
ETHOXYDIGLYCOL BEHENATE (UNII: N76ISC4ZZO)
CERESIN (UNII: Q1LS2UJO3A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Polysorbate 80 (UNII: 6OZP39ZG8H)
ALLANTOIN (UNII: 344S277G0Z)
PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)
CARBOMER 940 (UNII: 4Q93RCW27E)
CANOLA OIL (UNII: 331KBJ17RK)
Zinc Oxide (UNII: SOI2LOH54Z)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61566-100-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2013	09/15/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/15/2013	09/15/2017

Labeler - Kool-Down Inc. (146580548)

Registrant - Product Quest Mfg (927768135)

Name	Address	ID/FEI	Business Operations
Establishment
Product Quest Mfg		927768135	manufacture(61566-100) , label(61566-100)

Revised: 9/2017

Document Id: 18cd60e7-5fb3-439b-bba2-b53fcb3bd0ac

Set id: b5404d4b-1105-4419-a34d-0aeb3aee8d51

Version: 2

Effective Time: 20170915