Otc - Active Ingredient
Lidocaine 5% w/w
Oxify Cream
FDA Label NDC 11383-331
16 label sections · Submitted to the FDA by Weeks & Leo Compnay, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Weeks & Leo Compnay, Inc. for the product Oxify (NDC 11383-331). 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 - questions, warnings, otc - when using, otc - stop use, otc - ask doctor, 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
Otc - Purpose
Local anesthetic
Otc - Questions
Call 833-358-6431
Warnings
For External use only
Otc - When Using
- Avoid contact with 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
- rectal bleeding occurs
- condition worsens or does not improve within 7 days
- symptoms being treated do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
- symptoms clear up and return within a few days
Otc - Ask Doctor
- rectal bleeding occurs
- condition worsens or does not improve within 7 days
- symptoms being treated do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
- symptoms clear up and return within a few days
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
- when practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying
- adults and children 12 years and over: apply externally to the affected area up to 6 times a day
- children under 12 years: consult a doctor
Indications & Usage
Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders
Storage And Handling
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controoled Room Temperature]
Other Safety Information
Allergy alert: certain persons can develop allergic reactions to ingredients in this product.
Inactive Ingredient
acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbedenisis (aloe vera) leaf juice, benzyl alcohol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl stearate, isopropyl myristate, methylparaben, propylene glycol, steareth – 21, tocopheryl acetate, trolamine, water
Recent Major Changes
Changed Administration section to dosage and administration section
updated a spelling error in Directions toiled to toilet
Package Label.Principal Display Panel
Oxify
Lidocaine 5%
Anorectal (Hemorrhoidal) Cream
Relieves Pain, Itching, Burning
Net Wt. 6 oz (170 g)
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