FDA Label for Dibucaine

View Indications, Usage & Precautions

Dibucaine Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredients                                 PurposeDibucaine 1%...............................................Hemorrhoidal/Local analgesic ointment

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

* Please review the disclaimer below.