Active Ingredient(S)
Lidocaine 5.0%
Rectal Care Cream
FDA Label NDC 69168-484
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Rectal Care Cream (NDC 69168-484). 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(s), purpose, use(s), warnings, when using this product, stop use and ask a doctor if, if pregnant or breastfeeding,, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Local anesthetic
Use(S)
Helps relieve the pain, itching and burning associated with hemorrhoids
and other anorectal disorders
Warnings
For external use only.
When Using This Product
• 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
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
• symptoms clear up and return within a few days
If Pregnant Or Breastfeeding,
ask a health professional before use.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
• 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 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 at 15°-30° C (59°-86° F)
Inactive Ingredients
benzyl alcohol, carbomer, cholesterol, hydrogenated
lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopheryl acetate,
triethanolamine, water
Questions/Comments
Call 1-888-952-0050
(Monday-Friday 9 AM – 5 PM EST)
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Rectal Care Cream LabelRectal Care Cream Carton
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