Otc - Active Ingredient
Active Ingredients purpose
Lidocaine 5%........Local Anesthetic
Local Anesthetic Anorectal Cream
FDA Label NDC 84767-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Make Labs Llc for the product Local Anesthetic Anorectal Cream (NDC 84767-001). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
Temporary relief of pain, itching, and discomfort associated with hemorrhoids
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Stop use and ask a doctor if
- rectal bleeding occurs
- condition worsens or does not improve within 7 days
- 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.
Warnings
Warnings
For external use only
If pregnant or breast-feeding, ask a health professional before use.
Dosage & Administration
Directions
- Adults: When practical, clean affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Apply externally to the affected area up to 6 times a day.
- Children 12 and under, consult a physician prior to use.
Inactive Ingredient
Inactive ingredients Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Butyrospermum Parkii (Shea) Butter, Benzyl Alcohol, Cetearyl Alcohol, Ceteth-20, Carbomer, Cholesterol, Ethoxydiglycol, Lecithin, PPG-12/SMDI Copolymer, Propanediol, Polysorbate 60, Simmondsia Chinensis (Jojoba) Seed Oil, Water.
Package Label.Principal Display Panel
numbing.com
Local Anesthetic
Anorectal Cream
Net Wt. 6 OZ / 170g
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Tube Numbing Cream (Tube Numbing 50x152 4(1) 2)
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