LIDOCAINE 4% CREAM- lidocaine cream

Lidocaine 4% Cream by

Drug Labeling and Warnings

Lidocaine 4% Cream by is a Otc medication manufactured, distributed, or labeled by Galt Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Lidocaine 4%w/w

PURPOSE

Topical anesthetic

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.

USE(S)

Uses temporarily relieves pain and itching due to:

• minor cuts
• minor scrapes
• sunburn
• minor skin irritations
• minor burns
• insect bites

WARNINGS

For external use only.

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 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

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 doctor.

STORAGE

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

INACTIVE INGREDIENTS

Benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE 4% CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61825-701
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)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61825-701-05	10 in 1 CARTON	12/01/2014
1		5 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 not final	part348	12/01/2014

Labeler - Galt Pharmaceuticals, LLC (079214973)