Anecream

Dosage form: cream
Ingredients: LIDOCAINE 4g in 100g
Labeler: Focus Health Group
NDC Code: 24357-701

Disclaimer: 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 Facts:

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 InformationStore 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  
lidocaine 4% cream
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
1NDC:24357-701-301 TUBE (TUBE) in 1 CARTON
130 g in 1 TUBE
2NDC:24357-701-151 TUBE (TUBE) in 1 CARTON
215 g in 1 TUBE
3NDC:24357-701-075 TUBE (TUBE) 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/FEIOperations
DSC Laboratories, Div. of DSC Products Inc.097807374manufacture

Revised: 03/2010
 
Focus Health Group

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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