SPL v1
SPL
SPL Set ID 41d507c4-ad37-2686-e063-6394a90aae5b
Route
TOPICAL
Published
Effective Date 2025-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.04 g)
Inactive Ingredients
Propylparaben Water Polysorbate 80 Dihydroxyaluminum Aminoacetate Anhydrous Tartaric Acid Methylparaben Titanium Dioxide Sodium Polyacrylate (2500000 Mw) Povidone K90 Polyacrylic Acid (250000 Mw) Glycerin Kaolin Propylene Glycol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-03
Description

Adults and children 12 years old and over: Clean and dry the affected area. Apply 1 patch to the affected area. Do not exceed 1 patch at a time. Leave in place for up to 8 hours. Do not use more than 1 patch in 24 hours unless directed by a doctor. Children under 12 years old: ask a doctor.

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

For temporary relief of pain.

Dosage and Administration

Adults and children 12 years old and over:

  • Clean and dry the affected area.
  • Apply 1 patch to the affected area.
  • Do not exceed 1 patch at a time.
  • Leave in place for up to 8 hours.
  • Do not use more than 1 patch in 24 hours unless directed by a doctor.



    Children under 12 years old: ask a doctor.
Description

Adults and children 12 years old and over: Clean and dry the affected area. Apply 1 patch to the affected area. Do not exceed 1 patch at a time. Leave in place for up to 8 hours. Do not use more than 1 patch in 24 hours unless directed by a doctor. Children under 12 years old: ask a doctor.

Section 50565-1

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

Section 51727-6

Dihydroxyaluminum Aminoacetate, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Section 51945-4

Section 55105-1

Topical anesthetic.

Structured Label Content

Indications and Usage (34067-9)

For temporary relief of pain.

Dosage and Administration (34068-7)

Adults and children 12 years old and over:

  • Clean and dry the affected area.
  • Apply 1 patch to the affected area.
  • Do not exceed 1 patch at a time.
  • Leave in place for up to 8 hours.
  • Do not use more than 1 patch in 24 hours unless directed by a doctor.



    Children under 12 years old: ask a doctor.
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Dihydroxyaluminum Aminoacetate, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical anesthetic.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:53.693953 · Updated: 2026-03-14T23:13:21.652895