SPL v1
SPL
SPL Set ID 34156655-8706-f0a4-e063-6294a90acc90
Route
TOPICAL
Published
Effective Date 2025-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Hydroxypropyl Methylcellulose Aloe Barbadensis Leaf Benzalkonium Chloride Water Benzyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01
Description

Lidocaine HCL 4%

Medication Information

Warnings and Precautions
  • Keep out of reach of children, with cap securely closed.
  • For external use only.
  • If swallowed, immediately call Poison Control 800-222-1222
  • Avoid contact with the eyes.
  • If irritation occurs, stop and seek medical advice

Indications and Usage

For the temporary relief of pain.

Description

Lidocaine HCL 4%

Section 50565-1

Keep out of reach of children, with cap securely closed.

If swallowed, immediately call Poison Control 800-222-1222

Section 50566-9

DO NOT Use

  • In large quantities, particularly over raw surfaces or blistered areas.
  • If you are allergic to any ingredient in this product.
  • If you have an injury or perforation (hole) of the eardrum or tubes in the ear.
  • If you are running a fever, or notice a discharge.
  • If conditions worsen, or if symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Section 51727-6

Aloe Barbadensis Leaf Extract, Benzalkonium Chloride, Benzyl Alcohol, Hydroxypropyl Methycellulose, Water

Section 51945-4

WaxRx

EarAcheRx

Pain Relieving Drops

4% Lidocaine HC

0.5 FL OZ (15 ML)

Section 55105-1

Lidocaine HCL 4%...................Topical Anesthetic

Section 55106-9

Lidocaine HCL 4%

Easy to Use Directions

Adults and children 2 years and over

Apply 2 to 3 drops to affected area not more than 3 to 4 times daily.

Children under 2 years Consult a doctor.

Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of pain.

Warnings and Precautions (34071-1)
  • Keep out of reach of children, with cap securely closed.
  • For external use only.
  • If swallowed, immediately call Poison Control 800-222-1222
  • Avoid contact with the eyes.
  • If irritation occurs, stop and seek medical advice

Section 50565-1 (50565-1)

Keep out of reach of children, with cap securely closed.

If swallowed, immediately call Poison Control 800-222-1222

Section 50566-9 (50566-9)

DO NOT Use

  • In large quantities, particularly over raw surfaces or blistered areas.
  • If you are allergic to any ingredient in this product.
  • If you have an injury or perforation (hole) of the eardrum or tubes in the ear.
  • If you are running a fever, or notice a discharge.
  • If conditions worsen, or if symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Section 51727-6 (51727-6)

Aloe Barbadensis Leaf Extract, Benzalkonium Chloride, Benzyl Alcohol, Hydroxypropyl Methycellulose, Water

Section 51945-4 (51945-4)

WaxRx

EarAcheRx

Pain Relieving Drops

4% Lidocaine HC

0.5 FL OZ (15 ML)

Section 55105-1 (55105-1)

Lidocaine HCL 4%...................Topical Anesthetic

Section 55106-9 (55106-9)

Lidocaine HCL 4%

Easy to Use Directions

Adults and children 2 years and over

Apply 2 to 3 drops to affected area not more than 3 to 4 times daily.

Children under 2 years Consult a doctor.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:02.405568 · Updated: 2026-03-14T23:08:30.723878