LIDOCORE- lidocaine cream

Lidocore by

Drug Labeling and Warnings

Lidocore by is a Otc medication manufactured, distributed, or labeled by iON Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

drug facts Active ingredients

Drug Facts
Active ingredients: Purpose
Lidocaine HCI 4% Topical anesthetic

Uses

Uses: For temporary relief of pain.

Do not use section

Do not use on large areas of the body or on cut, irritated or swollen skin, on puncture wounds for more than one week without consulting a doctor

when using this product section

When using this product use only as directed. Read and follow all directions and warnings on this
carton. Do not allow contact with the eyes, do not bandage or apply local heat (such as heating pads) to the area of use

Stop use section

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

If pregnant or breastfeeding section

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children and pets section

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

Directions section

Directions: Adults, or children over the age of 12, apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period. Children 12 years and younger ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe barbadensis Leaf Juice, Aminomethyl Propanol, Cetearyl
Alcohol (and) Dicetyl Phosphate (and) Ceteth-10 Phosphate, Cyclopentasiloxane (and) Dimethicone/Vinyl Dimethicone Crosspolymer,
Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Phenoxyethanol, SD Alcohol, Steareth-21, Water.

Questions or comments section

Questions or Comments?
Call 833.711.8833 , info@ionpharmausa.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCORE 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82944-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	3.1 g  in 76.5 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
STEARETH-21 (UNII: 53J3F32P58)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
ALCOHOL 95% (UNII: 7528N5H79B)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
ISOHEXADECANE (UNII: 918X1OUF1E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82944-201-02	1 in 1 CARTON	09/13/2024
1		76.5 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/03/2024

Labeler - iON Pharma, LLC (118739596)