SPL v1
SPL
SPL Set ID 3ac4899d-3664-1bb3-e063-6394a90a3d4a
Route
TOPICAL
Published
Effective Date 2025-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Vitamin E Polyethylene Glycol Succinate Propylene Glycol Allantoin Phenoxyethanol Glycerin Water Carbomer Ethylhexylglycerin Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-29
Description

Lidocaine 4% --- Topical Anesthetic

Medication Information

Warnings and Precautions

For external use only

• For external use only

• Do not use on large areas of the body or on broken,

blistered, or abraded skin.

• Avoid contact with eyes,mouth,and mucous membranes.

• If pregnant or breastfeeding,consult a healthcare provider

before use

Indications and Usage

Temporarily helps reduce discomfort from:

Minor burns, insect bites, minor skin

irritations, Post-shaving or grooming sensitivity

External itching or rash due to dry skin

Dosage and Administration

▪ Adults and children over 12 years:

▪ Apply a thin layer to affected area not more than 3–4 times daily

▪ Children under 12 years: Consult a doctor before use

▪ Wash hands after application

Description

Lidocaine 4% --- Topical Anesthetic

Section 50565-1

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

Section 51727-6

Purified Water, Glycerin, Allantoin, Tocopheryl Acetate

(Vitamin E), Carbomer,Propylene Glycol,

Sodium Hydroxide, Phenoxyetha-nol, Ethylhexylglycerin

Section 51945-4

Section 55105-1

Local anesthetic

Section 55106-9

Lidocaine 4% --- Topical Anesthetic

Section 60561-8

Tamper evident: Do not use if seal is broken or missing.

Stop Use and Ask A Doctor If:

Condition worsens or symptoms persist for more than 7 days Skin irritation, rash or allergic reaction occurs.

Structured Label Content

Indications and Usage (34067-9)

Temporarily helps reduce discomfort from:

Minor burns, insect bites, minor skin

irritations, Post-shaving or grooming sensitivity

External itching or rash due to dry skin

Dosage and Administration (34068-7)

▪ Adults and children over 12 years:

▪ Apply a thin layer to affected area not more than 3–4 times daily

▪ Children under 12 years: Consult a doctor before use

▪ Wash hands after application

Warnings and Precautions (34071-1)

For external use only

• For external use only

• Do not use on large areas of the body or on broken,

blistered, or abraded skin.

• Avoid contact with eyes,mouth,and mucous membranes.

• If pregnant or breastfeeding,consult a healthcare provider

before use

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Purified Water, Glycerin, Allantoin, Tocopheryl Acetate

(Vitamin E), Carbomer,Propylene Glycol,

Sodium Hydroxide, Phenoxyetha-nol, Ethylhexylglycerin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Local anesthetic

Section 55106-9 (55106-9)

Lidocaine 4% --- Topical Anesthetic

Section 60561-8 (60561-8)

Tamper evident: Do not use if seal is broken or missing.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

Condition worsens or symptoms persist for more than 7 days Skin irritation, rash or allergic reaction occurs.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:40.678267 · Updated: 2026-03-14T23:09:34.496634