SPL v15
SPL
SPL Set ID 415368d8-12de-4688-8cf8-33382fca0dca
Route
TOPICAL
Published
Effective Date 2017-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Caprylyl Glycol Cetostearyl Alcohol Cyclomethicone 5 Glycerin Hexylene Glycol Phenoxyethanol Polysorbate 20 Polysorbate 60 Propylene Glycol Jojoba Oil Hyaluronate Sodium Sodium Lauryl Sulfate Edetate Sodium .alpha.-tocopherol Acetate Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-09-12
Description

LIDOCAINE HCL 4%

Purpose

TOPICAL ANALGESIC

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
Purpose

TOPICAL ANALGESIC

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

LIDOCAINE HCL 4%

Uses:

FOR THE TEMPORARY RELIEF OF

  • PAIN AND ITCHING
  • INSECT BITES
  • SUNBURN
  • MINOR CUTS
  • SCRAPES
  • BURNS
  • MINOR SKIN IRRITATIONS
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 Sulfate, Steric Acid, Tetrasodium EDTA, Tocopheryl Acetate, Sodium Hydroxide.

Section 51945-4

Section 53414-9

IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

Section 55105-1

PURPOSE:

topical analgesic

Warnings:

FOR EXTERNAL USE ONLY

Questions?

CALL 248.341.3401 9AM-2PM CENTRAL

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.

Other Information
  • STORE BETWEEN 58° - 87° F.
  • PROTECT FROM FREEZING, DIRECT HEAT OR SUNLIGHT.
Active Ingredients

LIDOCAINE HCL 4%

Inactive Ingredients:

CAPRYLYL GLYCOL, CETEARYL ALCOHOL, CYCLOPENTASILOXANE, DEIONIZED WATER, DIMETHYL SULFONE, GLYCERIN, HEXYLENE GLYCOL, PHENOXYETHANOL, POLYSORBATE 20, POLYSORBATE 60, PROPYLENE GLYCOL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SODIUM HYALURONATE, SODIUM HYDROXIDE, SODIUM LAURYL SULFATE, STEARIC ACID, TETRASODIUM EDTA, TOCOPHERYL ACETATE.

When Using This Product
  • KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
  • DO NOT USE IN LARGE UANTITIES, PARTICULARLY OVER RAW SURFACES OR BLISTERED AREAS.

Structured Label Content

Uses: (USES:)

FOR THE TEMPORARY RELIEF OF

  • PAIN AND ITCHING
  • INSECT BITES
  • SUNBURN
  • MINOR CUTS
  • SCRAPES
  • BURNS
  • MINOR SKIN IRRITATIONS
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 Sulfate, Steric Acid, Tetrasodium EDTA, Tocopheryl Acetate, Sodium Hydroxide.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

Section 55105-1 (55105-1)

PURPOSE:

topical analgesic

Purpose (PURPOSE)

TOPICAL ANALGESIC

Warnings: (WARNINGS:)

FOR EXTERNAL USE ONLY

Questions? (QUESTIONS?)

CALL 248.341.3401 9AM-2PM CENTRAL

Directions: (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.

Other Information (OTHER INFORMATION)
  • STORE BETWEEN 58° - 87° F.
  • PROTECT FROM FREEZING, DIRECT HEAT OR SUNLIGHT.
Active Ingredients

LIDOCAINE HCL 4%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

CAPRYLYL GLYCOL, CETEARYL ALCOHOL, CYCLOPENTASILOXANE, DEIONIZED WATER, DIMETHYL SULFONE, GLYCERIN, HEXYLENE GLYCOL, PHENOXYETHANOL, POLYSORBATE 20, POLYSORBATE 60, PROPYLENE GLYCOL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SODIUM HYALURONATE, SODIUM HYDROXIDE, SODIUM LAURYL SULFATE, STEARIC ACID, TETRASODIUM EDTA, TOCOPHERYL ACETATE.

When Using This Product (WHEN USING THIS PRODUCT)
  • KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
  • DO NOT USE IN LARGE UANTITIES, PARTICULARLY OVER RAW SURFACES OR BLISTERED AREAS.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:16.040110 · Updated: 2026-03-14T22:54:38.033285