FDA Label for Anecream
View Indications, Usage & Precautions
Anecream Product Label
The following document was submitted to the FDA by the labeler of this product Focus Health Group. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient:
Lidocaine 4% w/w
Purpose
Topical anesthetic
Uses
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 degC (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 ABOVE 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
* Please review the disclaimer below.
