ANECREAM- lidocaine 4% cream

Anecream by

Drug Labeling and Warnings

Anecream by is a Otc medication manufactured, distributed, or labeled by Focus Health Group, DSC Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Lidocaine 4% w/w

Purpose

Topical anesthetic

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

• 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

• 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

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.

Other Information

Store at USP controlled room temperature 20-25 degC (68-77 deg.F).

Inactive ingredients

benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopherol acetate, trolamine, water

Anecream 30g Tube

The product package shown represents a sample of that currently in use. Additional packaging may also be available.

Anecream Topical Anesthetic Cream

Net. Wt. 30g

Distributed by: Focus Health Group

Knoxville, TN 37919

INGREDIENTS AND APPEARANCE

ANECREAM 
lidocaine 4% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24357-701
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 (UNII: 4Q93RCW27E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24357-701-30	1 in 1 CARTON	06/01/2007
1		30 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 24357-701-15	1 in 1 CARTON	06/01/2007
2		15 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 24357-701-07	5 in 1 CARTON	06/01/2007
3	NDC: 24357-701-05	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	06/01/2007

Labeler - Focus Health Group (826939949)

Registrant - DSC Laboratories Inc. (097807374)

Establishment
Name	Address	ID/FEI	Business Operations
DSC Laboratories Inc.		097807374	manufacture(24357-701)