Lidocore Cream (lidocaine 4%)

Lidocore Cream (lidocaine 4%)
SPL v2
SPL
SPL Set ID 204c3e50-1ac8-f442-e063-6294a90ae7b5
Route
TOPICAL
Published
Effective Date 2024-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (3.1 g)
Inactive Ingredients
Glyceryl 1-stearate Ethylhexylglycerin Steareth-21 Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Dimethicone 350 Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Alcohol 95% Aloe Vera Leaf Phenoxyethanol Cyclomethicone 5 Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Edetate Disodium Anhydrous Water Aminomethylpropanol Ceteth-10 Phosphate Isohexadecane Cetostearyl Alcohol Dihexadecyl Phosphate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-03

Description

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


Medication Information

Description

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

Uses

Uses: For temporary relief of pain.

Section 51727-6

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.

Section 51945-4

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

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

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

Questions Or Comments Section

Questions or Comments?

Call 833.711.8833 , [email protected]

Drug Facts Active Ingredients

Drug Facts

Active ingredients: Purpose

Lidocaine HCI 4% Topical anesthetic

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

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.


Structured Label Content

Uses

Uses: For temporary relief of pain.

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

Stop Use Section (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

Directions Section (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

Do Not Use Section (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

Questions Or Comments Section (Questions or comments section)

Questions or Comments?

Call 833.711.8833 , [email protected]

Drug Facts Active Ingredients (drug facts Active ingredients)

Drug Facts

Active ingredients: Purpose

Lidocaine HCI 4% Topical anesthetic

When Using This Product Section (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

If Pregnant Or Breastfeeding Section (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 section)

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

Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)