Otc - Active Ingredient
Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, Phenylephrine HCl 0.25%
Bunnies Bum Soothing Hemorrhoidal Cream
FDA Label NDC 84308-161
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Flocal Distributors Llc for the product Bunnies Bum Soothing Hemorrhoidal (NDC 84308-161). 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 - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Glycerin-Protectant
Lidocaine-Local anesthetic
Petrolatum-Protectant
Phenylephrine HCl Vasoconstrictor
Indications & Usage
- For the temporary relief of pain, soreness, and burning
- Helps relieve the local itching and discomfort associated with hemorrhoids
- Temporarily shrinks hemorrhoidal tissue
- Temporarily provides a costing for the relief of anorectal discomforts
- Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
Warnings
For external use only.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
- avoid contact with eyes
- do not exceed recommended dosage unless directed by a doctor
- do not put this into the rectum by using fingers or any mechanical device or applicator
- 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
Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression
When using this product
Stop use and ask a doctor if
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
- Adults: 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 4 times a day, especially at night, in the morning, or after each bowel movement.
- Children under 12 years of age: consult a doctor.
Inactive Ingredient
Aloe barbadensis leaf extract, ascorbic acid, BHT, boswellia serrata extract, bromelain, cellulose gum, cetyl alcohol, citric acid, curcuma long (turmeric) root extract, disodium EDTA, ethylhexylglycerin, glucose, glyceryl stearate, mineral oil, panax ginseng root extract, panthenol, phenoxyethanol, propyl gallate, propylene glycol, salix alba (willow) bark extract, sorbitan olivate, steareth-21, stearyl alcohol, tocopherol, tocopheryl acetate, water, xanthan gum.
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