WALGREENS COOL N HEAT LIDOCAINE- lidocaine hcl 4% gel

Walgreens Cool n Heat Lidocaine by

Drug Labeling and Warnings

Walgreens Cool n Heat Lidocaine by is a Otc medication manufactured, distributed, or labeled by Walgreens Co, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine HCl 4%

PURPOSE

Topical analgesic

INDICATIONS & USAGE

For the temporary relief of pain.

WARNINGS

For external use only.

Flammable.Keep away from fire or flame.

Do not use inlarge quantities, particularly over raw surfaces or blistered areas.

When using this product

• avoid contact with eyes. In case of contact with eyes, flush thoroughly with water
• do not apply to wounds or damaged skin
• do not bandage tightly

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again with a few days
• redness or irritation develops

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Clean affected area before applying product. Adults and children 12 years and older, apply to affected area not more than 3 to 4 times daily. Children under 12 years old, ask a doctor.

INACTIVE INGREDIENT

Acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., aloe barbadensis leaf extract, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, methylparaben, steareth-21 water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WALGREENS COOL N HEAT LIDOCAINE 
lidocaine hcl 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-7801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE 200 (UNII: RGS4T2AS00)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
METHYLPARABEN (UNII: A2I8C7HI9T)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALCOHOL (UNII: 3K9958V90M)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARETH-21 (UNII: 53J3F32P58)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-7801-02	71 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/27/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/27/2023

Labeler - Walgreens Co (008965063)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(0363-7801)