Your browser does not support JavaScript! ANECREAM 5 (LIDOCAINE 5%) CREAM [FOCUS HEALTH GROUP]
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ANECREAM 5 (lidocaine 5%) cream
[Focus Health Group]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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 30g Tube Carton

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

Anecream5 Anorectal Cream

Net. Wt. 30g

Distributed by: Focus Health Group

Knoxville, TN 37919

Anecream5 30g Tube Carton

Anecream5 30g Tube Carton

ANECREAM 5 
lidocaine 5% cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:24357-702
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CARBOMER HOMOPOLYMER TYPE C 
CHOLESTEROL 
LECITHIN, SOYBEAN 
POLYSORBATE 80 
PROPYLENE GLYCOL 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
TROLAMINE 
WATER 
ISOPROPYL MYRISTATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24357-702-301 in 1 CARTON
130 g in 1 TUBE
2NDC:24357-702-151 in 1 CARTON
215 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34612/20/2011
Labeler - Focus Health Group (826939949)
Registrant - DSC Laboratories, Div. of DSC Products Inc. (097807374)
Establishment
NameAddressID/FEIBusiness Operations
DSC Laboratories, Div. of DSC Products Inc.097807374manufacture

Revised: 12/2011
 
Focus Health Group

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