Active Ingredient:
Lidocaine 5%
Lipocaine 5 Cream
FDA Label NDC 63135-811
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Esba Laboratories Inc. for the product Lipocaine 5 (NDC 63135-811). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient:, purpose, use, warnings, when using this product:, stop use and ask a doctor if:, keep out of the reach of children:, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 113 Grams Label (Labels Lipocaine 4 Oz 5 By 4.45 Rev1 X1200 Fda)
Lipocaine 5 tube 30 grams label
Label Lipocaine 5 (30 g tube)
Outer Carton Lipocaine 5 (30 g tube)
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