FDA Label for Lipocaine 5
View Indications, Usage & Precautions
Lipocaine 5 Product Label
The following document was submitted to the FDA by the labeler of this product Esba Laboratories Inc.. 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 5%
Purpose
Topical Anesthetic
Use
For temporary relief of pain and itching due to anorectal disorders.
Warnings
For external use only.
When Using This Product:
- avoid contact with eyes
- do not use in large quantities, particularly over raw surfaces or blistered areas
- do not put in rectum
- do not exceed recommended dosage unless directed by a doctor.
Stop Use And Ask A Doctor If:
- allergic reaction occurs
- rectal bleeding 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 The Reach Of Children:
If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions:
- When practical, clean area with mild soap and warm water and rinse thoroughly
- Gently dry by patting or blotting with toilet tissue or soft cloth before applying
- Adults and children 12 years old and older: Apply externally to the affected area up to 6 times a day
- Children under 12 years of age: consult a doctor.
Other Information:
- Store at room temperature 20-25oC (68-77oF).
- Child-Resistant Cap: push down and turn to open
- Available in 1 Oz (30 g) and 4 Oz (113 g) tubes
Inactive Ingredients:
Allantoin, Aloe Barbadensis Leaf Extract, Beta-Sitosterol, Caprylhydroxamic Acid, Cetyl Alcohol, Cetyl Palmitate, Glycerin, Glyceryl Caprylate, Isostearyl Alcohol, Lecithin, Purified Water, Sucrose Distearate, Sucrose Stearate , Tocopheryl Acetate, Triethylcitrate, Xanthan Gum.
Questions
Call toll-free in USA & Canada 800-677-9299 9 am - 5 pm (EST) M - F or visit www.esbalabs.com
Label On Tube And Outer Carton
Lipocaine 5 tube 113 grams label
Lipocaine 5 tube 30 grams label
Outer carton of Lipocaine 5 - 30 g tube
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