Otc - Active Ingredient
Active ingredients PurposeDibucaine 1%...............................................Hemorrhoidal/Local analgesic ointment
Dibucaine
FDA Label NDC 59779-398
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Dibucaine (NDC 59779-398). 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, otc - keep out of reach of children, indications & usage, warnings, 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
Active ingredients PurposeDibucaine 1%...............................................Hemorrhoidal/Local analgesic ointmentUses temporarily relieves pain and itching due to:- hemorrhoids or other anorectal disorders - sunburn - minor burns - minor cuts- scrapes - insect bites - minor skin irritation
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contacta Poison Control Center right away.
Indications & Usage
Uses temporarily relieves pain and itching due to:
- hemorrhoids or other anorectal disorders - sunburn - minor burns - minor cuts
- scrapes - insect bites - minor skin irritation
Other information- to secure child resistant cap; screw cap tightly. Then turn cap in opposite direction.If clicking sound is not heard, repeat procedure.- see crimp of tube for lot number and expiration date-store at controlled room temperature 20 degrees to 25 degrees c (68 degrees to 77 degrees F)
Warnings
Warnings For external use only. Allergy alert - certain persons san develop allergic reactions to ingredients in this productDo not use- in or near the eyes- do not get into the eyes- in infants under 2 years of age- in large quantities, particularly over raw surfaces or blistered areas- do not put this product into rectum by using fingers or any mechanical deviceStop use and ask a doctor if- condition worsens, or does not improve within 7 days- the symptom being treated does not subside or if redness, irritation, swelling, bleeding or other symptoms develop or increaseIf pregnant or breast feeding, as a health care professional before useKeep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
Directions - if possible clean the affected area with mild soap and warm water and rinse thoroughly- gently dry by patting or blotting with toilet tissue or a soft cloth before applyingAdults and children 12 and over - apply externally to the affected area up to 3 to 4 times a day.Children under 2 - 12 years of age - ask a doctorInfants under 2 years of age - DO NOT USE
Inactive Ingredient
Inactive Ingredientsacetone sodium bisulfite, lanolin, light mineral oil, purified water, white petrolatum
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