Otc - Active Ingredient
Active Ingredients .......5% Menthol.
Bellehaven Numbing Cream
FDA Label NDC 85284-009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bloomwell Gardens Llc for the product Bellehaven Numbing Cream (NDC 85284-009). 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 otc - active ingredient, inactive ingredient, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients
Tocopheryl Acetate, Emu Oil. Propylene Glycol, Arnica, Glycerin, Menthol, Aescinus Hippocastanum (Horse Chestnut)Extract, Lecithin(Soybean)Curcuma Longa Extract, Aqua
Indications & Usage
For the temporary relief of localized pain, itching or discomfort from minor skin irritations.
Warnings
Warnings (For external use only)
For external use only
Otc - When Using
·Do not get into the eyes.* Do not exceed recommended dosage unless directed by a doctor." Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Otc - Stop Use
Stop using and ask a doctor if
Condition worsens or does not improve within 7 days
Allergic reaction occurs to ingredients in this product.
Symptom being treated does not subside or if redness irritation, swelling, pain, or other symptoms develop or increase
Symptoms clear up and return within a few days.
Otc - Keep Out Of Reach Of Children
lf swallowed, get medical help. Do not use if allergic to any ingredients.
Otc - Pregnancy Or Breast Feeding
lf pregnant or breastfeeding, ask a health professional before use.
Dosage & Administration
When practical, clean the area within mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.
Adults and children 12 years and older: apply externally to the affected area up to 4 times a day.
Children under 12 years of age, consult a doctor.
To use finger cots: roll one finger cot cover the finger. Gently squeeze cream on to the finger cot. Smooth a layer of the cream.
Other Safety Information
Store at room temperature 59°-86°F（15-30°C）.Avoid direct sunlight. Do not use if tamper-evident packaging has been breached or is missing.
Otc - Purpose
Topical Analgesic
* Please review the disclaimer below.
