lidocaine 4% cream

lidocaine 4% cream
SPL v3
SPL
SPL Set ID 1baaa669-05af-4024-a0ba-ee3451756f6a
Route
topical
Published
Effective Date 2024-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g)
Inactive Ingredients
cetyl alcohol citric acid acetate mineral oil water white petrolatum glycerin glyceryl stearate se peg-100 stearate phenoxyethanol stearyl alcohol xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-05-22

Purpose

Topical Anesthetic

Description

Lidocaine 4% w/w


Medication Information

Warnings

For external use only.

Uses

Temporarily relieves pain and itching due to:

  • Minor cuts
  • Minor scrapes
  • Sunburn
  • Minor burns
  • Minor skin irritations
  • Insect bites
Purpose

Topical Anesthetic

Directions
  • Adults and children 2 years and older: apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years of age: consult a physician.
Other Information

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

Manufactured In USA For :

ONCOR PHARMACEUTICALS

8815 Center Park Dr Suite 430

Columbia

Maryland 21045

Inactive Ingredients

Cetyl alcohol, Citric acid, Glycerin, Glyceryl stearate SE, Mineral oil, PEG-100 stearate, Phenoxyethanol, Purified water, Stearyl alcohol, White

petrolatum, Xanthan gum.

Description

Lidocaine 4% w/w

Section 42229-5

See crimp of tube or carton for lot and exp. date.

RETAIN CARTON FOR COMPLETE DRUG FACTS.

Drug Facts

Lidocaine 4% w/w

Package Label

ONCOR PHARMACEUTICALS

NDC 83720- 523-01

Lidocaine 4% Cream

Topical Anesthetic Cream

For External Use Only

Not For Ophthalmic Use

This product contains child-resistant

packaging. To open, push down on the cap of the tube while turning and lift off.

NET WT. 1.05 OZ. (30 gm)

When Using This Product
  • Do not use in or near the eyes.
  • Do not use in large quantities, particularly over raw surfaces 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.
Keep Out of Reach of Children

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

You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7900 or FDA at 1-800-FDA-1088.


Structured Label Content

Warnings

For external use only.

Uses

Temporarily relieves pain and itching due to:

  • Minor cuts
  • Minor scrapes
  • Sunburn
  • Minor burns
  • Minor skin irritations
  • Insect bites
Purpose

Topical Anesthetic

Directions
  • Adults and children 2 years and older: apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years of age: consult a physician.
Other Information (Other information)

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

Manufactured In USA For :

ONCOR PHARMACEUTICALS

8815 Center Park Dr Suite 430

Columbia

Maryland 21045

Inactive Ingredients

Cetyl alcohol, Citric acid, Glycerin, Glyceryl stearate SE, Mineral oil, PEG-100 stearate, Phenoxyethanol, Purified water, Stearyl alcohol, White

petrolatum, Xanthan gum.

Section 42229-5 (42229-5)

See crimp of tube or carton for lot and exp. date.

RETAIN CARTON FOR COMPLETE DRUG FACTS.

Drug Facts

Lidocaine 4% w/w

Package Label

ONCOR PHARMACEUTICALS

NDC 83720- 523-01

Lidocaine 4% Cream

Topical Anesthetic Cream

For External Use Only

Not For Ophthalmic Use

This product contains child-resistant

packaging. To open, push down on the cap of the tube while turning and lift off.

NET WT. 1.05 OZ. (30 gm)

When Using This Product (When using this product)
  • Do not use in or near the eyes.
  • Do not use in large quantities, particularly over raw surfaces 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.
Keep Out of Reach of Children (Keep out of reach of children)

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

You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7900 or FDA at 1-800-FDA-1088.


Advanced Ingredient Data


Raw Label Data

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