Otc - Active Ingredient
Lidocaine 5%
Bunnies Bum Anorectal Numbing Spray
FDA Label NDC 84308-173
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 Anorectal Numbing (NDC 84308-173). 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
Topical anesthetic
Indications & Usage
Helps relieve the local itching and pain associated with anorectal disorders or inflammation.
Warnings
For external use only.
Flammable. Keep away from excessive heat or open flame.
When using this product
- 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
- contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.
- 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
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
- 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.
- 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.
Inactive Ingredient
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.
Package Label.Principal Display Panel
Label (Fcl Numsp 36 Printerproof)
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