Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 827e9c69-4706-0ccf-e053-2991aa0aa1c1
Route
TOPICAL
Published
Effective Date 2019-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Aloe Glycerin Stearic Acid Glyceryl Stearate Se Isopropyl Myristate Diethylene Glycol Monoethyl Ether Ceresin Polysorbate 80 Carboxypolymethylene Zinc Oxide Allantoin Ascorbic Acid Methylparaben Diazolidinyl Urea Propylparaben Trolamine Edetate Sodium .alpha.-tocopherol Acetate Almond Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-01-15
Description

Lidocaine - 4.0%

Medication Information

Warnings and Precautions

For external use only.

Do not use in large quantities, particularity over raw surfaces or blistered areas

When using this product keep out of eyes, use only as directed

Stop use and ask a doctor if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days.

Dosage and Administration

Adults and children 5 years of age and older: apply to affected area, not more than 3-4 times daily. Children under 5 years of age: ask a doctor.

Description

Lidocaine - 4.0%

Uses

Temporarily relieves pain due to: sunburns, burns, insect bites, and itching.

Section 50565-1

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

Section 51727-6

Aloe Barbadensis Leaf Juice, Glycerol, Stearic Acid, Glyceryl Stearate SE, Isopropyl Myristate, Ethoxydiglycol, Ozokerite, Polysorbate 80, Carbomer, Zinc Oxide, Allantoin, Ascorbic Acid, Methylparaben, Diazolidinyl Urea, Propylparaben, Triethanolamine, Tetrasodium EDTA, Tocopheryl Acetate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Fragrance.

Section 51945-4

Section 55105-1

Topical Pain Reliever

Section 55106-9

Lidocaine - 4.0%

Structured Label Content

Uses

Temporarily relieves pain due to: sunburns, burns, insect bites, and itching.

Dosage and Administration (34068-7)

Adults and children 5 years of age and older: apply to affected area, not more than 3-4 times daily. Children under 5 years of age: ask a doctor.

Warnings and Precautions (34071-1)

For external use only.

Do not use in large quantities, particularity over raw surfaces or blistered areas

When using this product keep out of eyes, use only as directed

Stop use and ask a doctor if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Aloe Barbadensis Leaf Juice, Glycerol, Stearic Acid, Glyceryl Stearate SE, Isopropyl Myristate, Ethoxydiglycol, Ozokerite, Polysorbate 80, Carbomer, Zinc Oxide, Allantoin, Ascorbic Acid, Methylparaben, Diazolidinyl Urea, Propylparaben, Triethanolamine, Tetrasodium EDTA, Tocopheryl Acetate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Fragrance.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Pain Reliever

Section 55106-9 (55106-9)

Lidocaine - 4.0%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:24.655099 · Updated: 2026-03-14T23:09:10.710567