SPL v2
SPL
SPL Set ID 731c9dc1-9b77-4d10-9851-d35eb777f7cd
Route
TOPICAL
Published
Effective Date 2015-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Caprylyl Glycol Cetostearyl Alcohol Cyclomethicone 5 Water Dimethyl Sulfone Glycerin Hexylene Glycol Phenoxyethanol Polysorbate 20 Polysorbate 60 Propylene Glycol Jojoba Oil Hyaluronate Sodium Sodium Lauryl Sulfate Stearic Acid Edetate Sodium .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-03-03
Description

Active Ingredients Lidocaine 4%

Medication Information

Warnings and Precautions

Warnings

For external use only

When using this product

  • Keep out of eyes. Rinse with water to remove.
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.
  • If pregnant or breast feeding, ask a health professional before use.
Indications and Usage

Uses for the temporary relief of

  • pain and itching
  • insect bites
  • sunburn
  • minor cuts
  • scrapes
  • burns
  • minor skin irritations
Dosage and Administration

Directions

Adults and children 2 years of age and older:

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

Children under 2 years of age: consult a doctor.

Description

Active Ingredients Lidocaine 4%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if conditions worsens, or, if symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use of the product and consult a doctor.

Section 51727-6

Inactive Ingredients

Caprylyl Glycol, Cetearyl Alcohol, Clyclopentasiloxane, Deionized water, Dimethyl Sulone, Glycerin, Hexylene Glycol, Phenoxyethanol, Polysorbate 20, Polysorbate 60, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium hyaluronate, Sodium Lauryl Sulfate, Stearic Acid, Tetrasodium EDTA, Tocopheryl Acetate

Section 51945-4

Section 55105-1

PURPOSE:

topical analgesic

Section 55106-9

Active Ingredients

Lidocaine 4%

Structured Label Content

Indications and Usage (34067-9)

Uses for the temporary relief of

  • pain and itching
  • insect bites
  • sunburn
  • minor cuts
  • scrapes
  • burns
  • minor skin irritations
Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and older:

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

Children under 2 years of age: consult a doctor.

Warnings and Precautions (34071-1)

Warnings

For external use only

When using this product

  • Keep out of eyes. Rinse with water to remove.
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.
  • If pregnant or breast feeding, ask a health professional 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 50566-9 (50566-9)

Stop use and ask a doctor if conditions worsens, or, if symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use of the product and consult a doctor.

Section 51727-6 (51727-6)

Inactive Ingredients

Caprylyl Glycol, Cetearyl Alcohol, Clyclopentasiloxane, Deionized water, Dimethyl Sulone, Glycerin, Hexylene Glycol, Phenoxyethanol, Polysorbate 20, Polysorbate 60, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium hyaluronate, Sodium Lauryl Sulfate, Stearic Acid, Tetrasodium EDTA, Tocopheryl Acetate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE:

topical analgesic

Section 55106-9 (55106-9)

Active Ingredients

Lidocaine 4%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:55.573742 · Updated: 2026-03-14T22:53:59.046955