COOLING GEL- lidocaine hcl gel

Cooling Gel by

Drug Labeling and Warnings

Cooling Gel by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, Kik Piedmont LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine HCI 0.5%

Purpose

Topical Analgesic

Uses

temporary relief of pain and itching associated with
sunburn, minor burns, minor cuts, scrapes, minor
skin irritations and insect bites.

Dosage & Administration

For the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, and poison oak.

Warnings

For external use only

Do not use

Do not use this in large quantities, particulary over raw
surfaces or blistered areas.

When using this product

When using this product avoid contact with eyes.

Stop use and ask a doctor if

Stop use and ask a doctor if condition worsens or if
symptoms persist for more than 7 days or symptoms
clear up and occur again within a few days.

Keep out of reach of children.

Keep out of reach of children. If swallowed get medical
help or contact a Poison Control Center right away.

Directions

adults and children 2 years of age and older: apply to
affected area not more than 3 to 4 times daily.
children under 2 years of age: do not use, ask a doctor.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Blue 1, Carbomer, Disodium
EDTA, Glycerin, Menthol,
Phenoxyethanol, Polysorbate 20,
Propanediol, SD Alcohol (1.85%
w/w), Sodium Hydroxide, Water,
Yellow 5

Questions or comments?

Questions or comments?
1-800-925-4733

Principal Display Panel

Walgreens

Compare to Solarcaine

active ingredient

Cooling Gel

LIDOCAINE HCl 0.5% /

PAIN RELIEVER

SOOTHES & RELIEVES PAIN

RESTORES MOISTURE

• For minor cuts & scrapes,

insect bites, burns & sunburn

• Topical analgesic
• Contains aloe vera

NET WT 8OZ (226 g)

PKLA-41206-WGF1

INGREDIENTS AND APPEARANCE

COOLING GEL 
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-8897
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPANEDIOL (UNII: 5965N8W85T)
ALCOHOL (UNII: 3K9958V90M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
BASIC YELLOW 5 (UNII: 07BP340B4T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-8897-34	226 g in 1 BOTTLE; Type 0: Not a Combination Product	01/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/07/2019

Labeler - Walgreen Company (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
Kik Piedmont LLC		078482780	manufacture(0363-8897)