Purpose
Anorectal (hemorrhoidal)
Healthwise Anorectal Pain Relief Spray
FDA Label NDC 71101-069
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Healthwise Anorectal Pain Relief (NDC 71101-069). 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 purpose, uses, warnings, stop use and ask a doctor if, when using this product, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
helps relieve the local itching and pain associated with
anorectal disorders or inflammation
Warnings
For external use only
Flammable Do not use while smoking or near heat or flame
Stop Use And Ask A Doctor If
• rectal bleeding occurs
• condition worsens or does not improve within 7 days
• allergic reaction occurs to ingredients in this product
• symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
When Using This Product
• avoid spraying in 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
• contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
• when practical, cleanse the affected area with mild soap and warm water
• rinse thoroughly and gently pat dry
• spray affected area • wash hands after applying
• replace cap after use
• adults and children 12 years and older:apply externally to the affected area up to 6 times a day
• children under 12 years of age:consult a doctor
Other Information
Store out of direct sunlight, in a cool dry, well-ventilated area
Inactive Ingredients
alcohol denat, aloe barbadensis leaf extract, carbomer, chamomilla recutita (matricaria) flower extract, cucumis sativus (cucumber) fruit extract, disodium cocoamphodipropionate, disodium EDTA, glycerin, propylene glycol, tocopheryl acetate, triethanolamine, water
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