ANECREAM 5- lidocaine 5% cream

Anecream 5 by

Drug Labeling and Warnings

Anecream 5 by is a Otc medication manufactured, distributed, or labeled by Focus Health Group, DSC Laboratories Inc., DSC Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

temporarily relieves pain and itching due to anorectal disorders

Warnings

When using this product

• avoid contact with eyes
• do not exceed recommended dosage unless directed by a doctor
  

Stop and ask a doctor if

• rectal bleeding occurs
• condition worsens or does not improve within 7 days
• allergic reaction occurs
• redness, irritation, swelling, pain or other symptoms begin or increase
• symptoms clear up and return within a few days

Keep out of reach of children.

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

Directions

• When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting of blotting with toilet tissue or soft cloth before applying.
• Adults and children 12 years and older: Apply to the affected area up to 6 times a day.
• Children under 12 years of age: Consult a doctor.
  

Other information

Store at USP controlled room temperature 20-25C (66-77F).

Inactive ingredients

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

Anecream5 15g Tube Carton

AC 5art 15gm.jpg

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

Anecream5 Anorectal Cream

Net. Wt. 15g

Distributed by: Focus Health Group

Knoxville, TN 37919

Anecream5 15g Tube Carton

INGREDIENTS AND APPEARANCE

ANECREAM 5 
lidocaine 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24357-702
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 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)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24357-702-15	1 in 1 CARTON	12/20/2011
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 24357-702-30	1 in 1 CARTON	05/21/2019
2		30 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 final	part346	12/20/2011

Labeler - Focus Health Group (826939949)

Registrant - DSC Laboratories Inc. (097807374)

Establishment
Name	Address	ID/FEI	Business Operations
DSC Laboratories, Inc.		097807374	manufacture(24357-702)