SPL v1
SPL
SPL Set ID 98e0673f-00e8-4eb0-a1d1-78baae6b6c7b
Route
TOPICAL
Published
Effective Date 2014-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (.5 g)
Inactive Ingredients
Water Alcohol Propylene Glycol Lactic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-06-15
Description

Lidocaine 0.5%

Medication Information

Description

Lidocaine 0.5%

Uses

External Analgesic

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if:

  • condition worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days
Warnings

For external use only, avoid contact with eyes. Do not use in large quantities, particularly over raw surfaces or blistered surfaces

Directions
  • Adults and children 2 years and older: apply to affected area. Do not use more than 3-4x daily. Repeat daily until healed.
  • Children under 2 years of age: consult a doctor
Indications

For temporary relief of pain associated with sunburn and minor skin burns.

Package Display

Active Ingredients

Lidocaine 0.5%

Inactive Ingredients

Water, Ethanol, Propylene Glycol, Lactic Acid

Structured Label Content

Uses

External Analgesic

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

  • condition worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days
Warnings

For external use only, avoid contact with eyes. Do not use in large quantities, particularly over raw surfaces or blistered surfaces

Directions
  • Adults and children 2 years and older: apply to affected area. Do not use more than 3-4x daily. Repeat daily until healed.
  • Children under 2 years of age: consult a doctor
Indications

For temporary relief of pain associated with sunburn and minor skin burns.

Package Display

Active Ingredients

Lidocaine 0.5%

Inactive Ingredients

Water, Ethanol, Propylene Glycol, Lactic Acid

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:57.470543 · Updated: 2026-03-14T22:54:02.195419