Active Ingredient
Lidocaine 5% ......................................... Local anesthetic
Anievalc Cream
FDA Label NDC 87798-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Blackstone Products, Llc for the product Anievalc (NDC 87798-001). 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, uses, warnings, if pregnant or breast-feeding,, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Local anesthetic
Uses
- For the temporary relief of local and anorectal itching and discomfort associated with hemorrhoids and other anorectal disorders.
- For the temporary relief of pain, soreness and burning.
Warnings
For external use only
- if condition worsens or does not improve within 7 days, consult a doctor.
- Do not exceed the recommended daily dosage unless directed by a doctor.
In case of bleeding, consult a doctor promptly.
Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years of age and over:When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
Apply externally to the affected area up to 6 times daily.
Children under 12 years of age: consult a doctor.
Other Information
Store at USP controlled room temperature 20°-25°C (68°-77°F)
Child-resistant packaging. Close cap tightly after use.
Inactive Ingredients
Aloe Vera Extract, Arnica Montana Flower Extract, Carbomer, Cetostearyl Alcohol, C10-18 Triglycerides, Dimethicone, Edetate Disodium, Ethylhexylglycerin, Glyceryl Mono- and Dipalmitostearate, Hydroxyacetophenone, Isopropyl Myristate, Polysorbate 60, Propylene Glycol, Vitamin E, Water
Questions?
(800) 971-5459
Other
Distributed by:
Blackstone Products, LLC
Sacramento, CA 95811
Package Label.Principal Display Panel
PRINCIPAL DISPLAY PANEL
1 (Label 1)
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