Numstick
FDA Label NDC 67194-014

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unit Dose, Ltd. for the product Numstick (NDC 67194-014). 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 in each gram, uses:, warning:, do not use:, stop use and ask a doctor:, keep out of reach of children, directions:, ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient In Each Gram

Petrolatum (White) 60%

Lidocaine 5.0%

Uses:

Temporary relief of anorectal discomfort

Warning:

External Use Only. Keep out of eyes.. You may develop allergic reaction to ingredients.

Do Not Use:

More than directed or in the rectum with any mechanical device or applicator.

Stop Use And Ask A Doctor:

if pain worsens, or bleeding or swelling occurs

Keep Out Of Reach Of Children

and get medical help right away if swallowed.

Directions:

Apply .5-1.0 gm. to desired clean dry area up to 4 times/day as needed.

Ingredients:

Simmondisa Chinensis (Jojoba) Seed oil, Lanolin, Beeswax, Ozokerite wax, Candelilla wax, Paraffin, Ethoxydiglycol, Menthol, Tocopheryl Acetate, Cholecalciferol, Retinyl Palmitate, Phytonadione

* Please review the disclaimer below.