Otc - Active Ingredient
Lidocaine 5%
Bottoms Up
FDA Label NDC 69797-103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wsm Investment Llc Dba Topco Sales for the product Bottoms Up (NDC 69797-103). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anorectal
Indications & Usage
For temporary relief of pain, soreness, or burning in the perianal area.
Warnings
- For external use only. Do not use this product with a mechanical device.
- Certain persons can develop allergic reactions to ingredients in this product.
- Do not exceed the daily recommended dosage
- In case of any bleeding, discontinue use and consult a doctor.
- Avoid contact with eyes, in case of eye contact, flush with water.
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.
Otc - Keep Out Of Reach Of Children
- Keep this and all drugs out of reach of children. If swallowed, seek medical help or call a Poison Control Center right away.
- As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.
Dosage & Administration
- Cleanse affected area with mild soap and water.
- Gently dry by patting or blotting with soft cloth or tissue before application.
- Apply externally to the affected area up to 6 times daily.
Other Safety Information
- Store at room temperature 20-25°C (68-77°F).
- Tamper-Evident: Do not use if tamper evident seal under cap is broken or missing.
Inactive Ingredient
Cellulose Gum, Diazolidinyl Urea, Glycerin, Isopentyldiol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water (Aqua).
* Please review the disclaimer below.
