SPL v2
SPL
SPL Set ID 3f74c4a6-26f0-ddf7-e063-6394a90a1225
Route
TOPICAL
Published
Effective Date 2025-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Menthol Polysorbate 80 Glycerin Soybean Lecithin Propylene Glycol Trolamine Aloe Vera Leaf Juice Phenoxyethanol Caprylic/capric Triglyceride Allantoin Ethylhexylglycerin Carbomer Alpha-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-23
Description

Lidocaine 4%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

For use as a local anesthetic to numb the skin prior to minor medical or cosmetic procedures

Dosage and Administration

■ Adults: When practical, clean and dry the affected area. Apply externally to the affected area up to 3 times daily. ■ Children under 12 years of age: consult a doctor.

Description

Lidocaine 4%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

■ condition worsens or does not improve within 7 days ■ rectal bleeding occurs ■ allergic reaction occurs to ingredients in this product ■ symptoms being treated do not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

Section 50567-7

■ avoid contact with eyes or mucous membranes ■ Use only as directed ■ do not put this product into the rectum by using fingers or any mechanical device or applicator

Section 51727-6

Purified Water, Propylene Glycol, Glycerin, Caprylic/Capric Triglyceride, Lecithin, Polysorbate 80, Aloe Vera Leaf Juice, Carbomer, Triethanolamine, Tocopheryl Acetate, Allantoin, Menthol, Phenoxyethanol, Ethylhexylglycerin.

Section 51945-4

Section 53413-1

Email at:

[email protected]

Section 55105-1

For temporary relief of minor pain, burning and soreness.

Section 55106-9

Lidocaine 4%

Section 60561-8

■ Store at room temperature 15–30°C (59–86°F) ■ Keep away from direct sunlight or heat

Structured Label Content

Indications and Usage (34067-9)

For use as a local anesthetic to numb the skin prior to minor medical or cosmetic procedures

Dosage and Administration (34068-7)

■ Adults: When practical, clean and dry the affected area. Apply externally to the affected area up to 3 times daily. ■ Children under 12 years of age: consult a doctor.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

■ condition worsens or does not improve within 7 days ■ rectal bleeding occurs ■ allergic reaction occurs to ingredients in this product ■ symptoms being treated do not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

Section 50567-7 (50567-7)

■ avoid contact with eyes or mucous membranes ■ Use only as directed ■ do not put this product into the rectum by using fingers or any mechanical device or applicator

Section 51727-6 (51727-6)

Purified Water, Propylene Glycol, Glycerin, Caprylic/Capric Triglyceride, Lecithin, Polysorbate 80, Aloe Vera Leaf Juice, Carbomer, Triethanolamine, Tocopheryl Acetate, Allantoin, Menthol, Phenoxyethanol, Ethylhexylglycerin.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Email at:

[email protected]

Section 55105-1 (55105-1)

For temporary relief of minor pain, burning and soreness.

Section 55106-9 (55106-9)

Lidocaine 4%

Section 60561-8 (60561-8)

■ Store at room temperature 15–30°C (59–86°F) ■ Keep away from direct sunlight or heat

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:04.873562 · Updated: 2026-03-14T23:13:40.815212