FDA Label for Oxify
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - ASK DOCTOR
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - PURPOSE
- OTC - QUESTIONS
- OTC - STOP USE
- OTC - WHEN USING
- WARNINGS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INDICATIONS & USAGE
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- RECENT MAJOR CHANGES
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Oxify Product Label
The following document was submitted to the FDA by the labeler of this product Weeks & Leo Compnay, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Lidocaine 5% w/w
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 - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Purpose
Local anesthetic
Otc - Questions
Call 833-358-6431
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 - 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
Warnings
For External use only
Dosage & Administration
- when practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toiled 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
Storage And Handling
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controoled Room Temperature]
Indications & Usage
Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders
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 barbadensis (aloe vera) leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate
Recent Major Changes
Changed Administration section to dosage and administration section
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