Active Ingredient
Lidocaine 5%
Hemorrhoid Pain Relief Cream
FDA Label NDC 73287-028
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Telebrands Corp for the product Hemorrhoid Pain Relief (NDC 73287-028). 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, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Lidocaine 5%................Local Anesthetic
Uses
For the temporary relief of pain, burning, itching and discomfort associated with hemorrhoids.
Warnings
For external use only
Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Otc - When Using
When using this product
- do not exceed the recommended daily dosage unless directed by a doctor.
- use only as directed. Read and follow all directions and warnings on this label.
- do not put this product into the rectum by using finger or any mechanical device or applicator.
Otc - Stop Use
Stop use and ask a doctor if
- if condition worsens or does not improve within 7 days
- in case of bleeding
- symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Certain persons can develop allergic reactions to ingredients in this product.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Adults: 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 to affected area.
- Apply to the affected area up to 6 times a day
- Children under 12 years of age: consult a doctor.
Other Information
- Do not use if seal is broken or missing
Inactive Ingredients
Water/Aqua/Eau, Ethylhexyl Stearate,Butylene Glycol, Dimethicone, Stearic Acid, Caprylic/Capric Triglyceride,Cannabis Sativa (Hemp) Seed Oil, Glyceryl Stearate, PEG-100 Stearate, CetearylAlcohol, Helianthus Annuus (Sunflower) Seed Oil, Curcuma Longa (Turmeric)Root Extract, Allantoin, Glycerin, Tocopheryl Acetate, Acrylates/C10-30 AlkylAcrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin,Hexylene Glycol, Sodium Hydroxide, Disodium EDTA
Questions?
Call (855) 877-4503 (M-F, 9am-5pm EST)
Package Label.Principal Display Panel
Hempvana
NDC 73287-028-01
Maximum OTC Strength
Hemorrhoid Pain Relief
Topical Anesthetic Cream
5% Lidocaine
+ Hemp Seed Oil For Moisturization
Net Wt. 3oz (85g)
100% Fragrance Free
* Please review the disclaimer below.
