Lidocaine Cream

Lidocaine Cream
SPL v4
SPL
SPL Set ID dcc5a175-97a0-4e5f-a74d-1a7059d0bfff
Route
TOPICAL
Published
Effective Date 2025-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Benzyl Alcohol Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Cholesterol Hydrogenated Soybean Lecithin Isopropyl Myristate Polysorbate 80 Trolamine .alpha.-tocopherol Acetate, D-

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-01

Description

Drug Facts

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Drug Facts

Uses

For temporary relief of pain associated with minor cuts, minor burns, minor scrapes, sunburn, minor skin irritations, and insect bites.

Section 42229-5

Drug Facts

Warnings

For external use only.

Directions
  • Adults and children 2 years and older. Apply externally to the affected area up to 3 to 4 times a day.

  • Children under 2 years of age. Consult a doctor.
Questions?

1-800-697-3329

Other Information

Store at USP controlled room temperature 20-25 °C (68-77 °F).

Active Ingredients

Lidocaine 4% w/w

Inactive Ingredients

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, Vitamin E Acetate.

When Using This Product
  • do not get into eyes.

  • do not exceed the recommended daily dosage unless directed by a doctor

  • do not use in large quantities, particularly over raw or blistered areas.
Stop Use and Ask A Doctor If
  • allergic reaction occurs

  • condition worsens or does not improve within 7 days

  • symptoms clear up and return within a few days

  • redness, irritation, swelling, pain or other symptoms begin or increase.
If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get help or contact a Poison Control Center right away.

Principal Display Panel 28 G Tube Box

Nationwide

Pharmaceutical

NDC 69375-0005-30

4% Lidocaine

Topical Anesthetic Cream

NET WT 1 oz (28 g)


Structured Label Content

Uses

For temporary relief of pain associated with minor cuts, minor burns, minor scrapes, sunburn, minor skin irritations, and insect bites.

Section 42229-5 (42229-5)

Drug Facts

Purpose

Local Anesthetic

Warnings

For external use only.

Directions
  • Adults and children 2 years and older. Apply externally to the affected area up to 3 to 4 times a day.

  • Children under 2 years of age. Consult a doctor.
Questions?

1-800-697-3329

Other Information

Store at USP controlled room temperature 20-25 °C (68-77 °F).

Active Ingredients (Active ingredients)

Lidocaine 4% w/w

Inactive Ingredients (Inactive ingredients)

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, Vitamin E Acetate.

When Using This Product (When using this product)
  • do not get into eyes.

  • do not exceed the recommended daily dosage unless directed by a doctor

  • do not use in large quantities, particularly over raw or blistered areas.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • allergic reaction occurs

  • condition worsens or does not improve within 7 days

  • symptoms clear up and return within a few days

  • redness, irritation, swelling, pain or other symptoms begin or increase.
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get help or contact a Poison Control Center right away.

Principal Display Panel 28 G Tube Box (PRINCIPAL DISPLAY PANEL - 28 g Tube Box)

Nationwide

Pharmaceutical

NDC 69375-0005-30

4% Lidocaine

Topical Anesthetic Cream

NET WT 1 oz (28 g)


Advanced Ingredient Data


Raw Label Data

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