LIDOCAINE ANESTHETIC CREAM- lidocaine cream

Lidocaine Anesthetic Cream by

Drug Labeling and Warnings

Lidocaine Anesthetic Cream by is a Otc medication manufactured, distributed, or labeled by Nationwide Pharmaceutical LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Lidocaine 4% w/w

Purpose

Local Anesthetic

Uses

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

Warnings

For external use only.

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.

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.

Other Information

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

Inactive ingredients

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

Questions?

1-800-697-3329

PRINCIPAL DISPLAY PANEL - 28 g Tube Box

Nationwide
Pharmaceutical

NDC: 69375-0005-30

4% Lidocaine
Topical Anesthetic Cream

NET WT 1 oz (28 g)

INGREDIENTS AND APPEARANCE

LIDOCAINE ANESTHETIC CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69375-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69375-005-30	1 in 1 BOX	06/01/2022
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/01/2022

Labeler - Nationwide Pharmaceutical LLC (079265801)