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

781_30g

ANECREAM
lidocaine 4% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24357-701
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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
4	NDC:24357-701-06	5 in 1 CARTON	03/11/2011
4	NDC:24357-701-05	5 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC:24357-701-50	50 in 1 CARTON	08/01/2020
5	NDC:24357-701-01	2.5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	06/01/2007

Labeler - Focus Health Group (826939949)

Registrant - DSC Laboratories Inc. (097807374)

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

Anecream 4%