Active Ingredient
Lidocaine 5%
Numbskin Maximum Strength Pain Reliever Cream
FDA Label NDC 69903-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shinpharma Inc for the product Numbskin Maximum Strength Pain Reliever (NDC 69903-008). 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, when using this product, stop use and ask a doctor if, keep out of 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
Anorectal (Hemorrhoidal)
Uses
For temporary relief of local discomfort, itching, soreness or burning in the perianal area associated with anorectal disorders
Warnings
For external use only
When Using This Product
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put into the rectum by using fingers or any mechanical device or applicator
Stop Use And Ask A Doctor If
- allergic reaction occurs
- rectal bleeding occurs
- redness, irritation, swelling, pain or other symptoms begin or increase
- condition worsens or does not improve within 7 days
Keep Out Of Reach Of Children
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.
- When first opening the tube, twist the cap and peel off the foil seal
- Apply externally to the affected area up to 6 times daily
- Children under 12 years: Consult a doctor
Other Information
- always keep the tube tighlty closed
- store at temperatures not exceeding 59°F - 86°F (15°C-30°C)
- protect from freezing
Inactive Ingredients
Benzyl Alcohol, Carbopol, Letcithin, Propylene Glycol, Tocopheryl Acetate, Water
Questions?
Contact our dedicated Customer Care at +1 (877) 786 2001 or email us at [email protected]
Principal Display Panel
NDC 69903-007-02
Numbskin Maximum Strength Pain Reliever
Label (30)
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