Label: ANECREAM - lidocaine 4% cream
- NDC Code(s): 24357-701-05, 24357-701-07, 24357-701-15, 24357-701-30
- Packager: Focus Health Group
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated March 22, 2010
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- Active Ingredient:
Lidocaine 4% w/wClose
temporarily relieves pain and itching due to:
- minor cuts
- minor scrapes
- minor skin irritations
- minor burns
- insect bites
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
- 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
- INGREDIENTS AND APPEARANCE
lidocaine 4% cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24357-701 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24357-701-30 1 in 1 CARTON 1 30 g in 1 TUBE 2 NDC:24357-701-15 1 in 1 CARTON 2 15 g in 1 TUBE 3 NDC:24357-701-07 5 in 1 CARTON 3 NDC:24357-701-05 5 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/01/2007 Labeler - Focus Health Group (826939949) Registrant - DSC Laboratories, Div. of DSC Products Inc. (097807374) Establishment Name Address ID/FEI Business Operations DSC Laboratories, Div. of DSC Products Inc. 097807374 manufacture