3b5e1a74-5946-4f1f-e063-6394a90a404b

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.

Active Ingredient

Lidocaine 4%

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.


Structured Label Content

Warnings and Precautions (34071-1)

Warnings For external use only.

Active Ingredient (55106-9)

Lidocaine 4%

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

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.


Advanced Ingredient Data


Raw Label Data

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