Your browser does not support JavaScript! ANECREAM (LIDOCAINE 4%) CREAM [FOCUS HEALTH GROUP]
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ANECREAM (lidocaine 4%) cream
[Focus Health Group]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not 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 4% w/w

Purpose


Topical anesthetic

Use:

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 deg.C (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 below 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

ANECREAM 30G CARTON

Anecream 30g Tube Carton


ANECREAM  
lidocaine 4% cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:24357-701
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE4 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 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24357-701-301 in 1 CARTON
130 g in 1 TUBE
2NDC:24357-701-151 in 1 CARTON
215 g in 1 TUBE
3NDC:24357-701-075 in 1 CARTON
3NDC:24357-701-055 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2007
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: 3/2010
 
Focus Health Group

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