Active Ingredient
Lidocaine 5%
Lidocaine Cream
FDA Label NDC 73581-114
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yyba Corp for the product Lidocaine (NDC 73581-114). 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, purpose, usages, warnings, otc - keep out of reach of children, directions, inactive ingrediants, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anorectal (hemorrhoidal) cream
Usages
Temporarily relieves the pain and itching due to anorectal disorders.
Warnings
For external use only.
When using this product
avoid contact with eyes
do not exceed recommended dosage unlesss directed by a doctor
do not use in large quantaties, particularly over large surfaces or blistered areas
do not put this product into the rectum by using fingers or any medical devices or applicators
Stop and ask a doctor if
rectal bleeding occurs
condition worsens or does not improve within 7 days
allergic reaction occurs to ingredients in the product
symptoms being treated do not subsise or if redness, irritation, swelling, pain or other symptoms develop or increase
symptoms clear up and return within a few days
Flammable
keep away from fire or flame
If pregnant or breast feading, as a health professional before use.
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center Right Away
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center Right Away
Directions
When practical, cleanse the affected 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.
Inactive Ingrediants
benzyl alcohol, carbomer hompolymer type C, Cl 0-18 triglycerides, cholesterol, lecithin, isopropyl myristate,
polysorbate 80, propylene glycol, tocopherol, trolamine, water.
* Please review the disclaimer below.
