SPL v3
SPL
SPL Set ID 3b5e1a74-5946-4f1f-e063-6394a90a404b
Route
TOPICAL
Published
Effective Date 2025-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Menthol Hydrogenated Soybean Lecithin Propylene Glycol Glycerin Curcuma Longa (turmeric) Root Aqua Arnica Montana Flower .alpha.-tocopherol Acetate Emu Oil Horse Chestnut

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01

Description

Lidocaine 4%


Medication Information

Warnings and Precautions

Warnings For external use only.

Indications and Usage

DirectionsClean the affected area with mild soap andwarm water, then rinse thoroughly andpat dry. For adults and children over 12 years old:Apply externally to the affected a-rea up to 4 timesa day. For children under 12 years: Consult adoctor before use.Using Finger Cots: Roll a fnger cot over your fnger.Apply a small amount of creamonto the fngertip.Evenly spread a thin layer of the cream over the skin.

Dosage and Administration

Apply externally to the affected a-rea up to 4 timesa day

Description

Lidocaine 4%

Section 50565-1

Safetyinformation Keep out of reach of children.if ingested, seek medical attention immediately. Do not use if you have allergiesto any of the ingredients.m if you are pregnant or breastfeeding consult a healthcareprovider before use.

Section 50566-9

Discontinue use and consult a doctor if:Your condition worsens or does not improve within 7 days ou exper-ience anallergicreaction to any ingredient in this product.Symptoms persist, or redness.irritation, swellingor pain intensifes Symptoms improve but return after a few days.

Section 51727-6

Inactive Ingredients:Tocopheryl Acetate, Emu Oil, Propylene Glycol, Arica, Glycerin,MentholAesculus Hippocastanum (Horse Chestnut) Extract,Lecithin (Soybean),Curcuma Longa Extract, Aqua.

Section 51945-4

Section 55105-1

UsesFor the temporary relief of pain and itching due to minor burns, sunburn, insectbites,scrapes, cuts, and minor skin irritations.

Section 55106-9

Lidocaine 4%


Structured Label Content

Indications and Usage (34067-9)

DirectionsClean the affected area with mild soap andwarm water, then rinse thoroughly andpat dry. For adults and children over 12 years old:Apply externally to the affected a-rea up to 4 timesa day. For children under 12 years: Consult adoctor before use.Using Finger Cots: Roll a fnger cot over your fnger.Apply a small amount of creamonto the fngertip.Evenly spread a thin layer of the cream over the skin.

Dosage and Administration (34068-7)

Apply externally to the affected a-rea up to 4 timesa day

Warnings and Precautions (34071-1)

Warnings For external use only.

Section 50565-1 (50565-1)

Safetyinformation Keep out of reach of children.if ingested, seek medical attention immediately. Do not use if you have allergiesto any of the ingredients.m if you are pregnant or breastfeeding consult a healthcareprovider before use.

Section 50566-9 (50566-9)

Discontinue use and consult a doctor if:Your condition worsens or does not improve within 7 days ou exper-ience anallergicreaction to any ingredient in this product.Symptoms persist, or redness.irritation, swellingor pain intensifes Symptoms improve but return after a few days.

Section 51727-6 (51727-6)

Inactive Ingredients:Tocopheryl Acetate, Emu Oil, Propylene Glycol, Arica, Glycerin,MentholAesculus Hippocastanum (Horse Chestnut) Extract,Lecithin (Soybean),Curcuma Longa Extract, Aqua.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

UsesFor the temporary relief of pain and itching due to minor burns, sunburn, insectbites,scrapes, cuts, and minor skin irritations.

Section 55106-9 (55106-9)

Lidocaine 4%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)