Active Ingredient
Lidocaine 5%
Lidocaine Hydrochloride Cream
FDA Label NDC 73581-120
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 Hydrochloride (NDC 73581-120). 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, uses, warnings, stop use and ask a doctor if, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anorectal (hemorrhoidal) anesthetic
Uses
Temporarily relieves the pain and itching due to anorectal disorders.
Warnings
For external use only. When using this product
- avoid contact with etes
- do not use in large quantities, particulary over large surfaces or blistered areas
- do not exceed recommended dosage unless directed by a doctor
- do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop Use And Ask A Doctor If
- 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 inscrease
- symptoms clear up and return within a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison 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
Other Information
Store at 25°C (77°F): excursions permitted to 15°-30°C(59°-86°F)[see USP Controlled Room Temperature].
Inactive Ingredients
aloe barbadensis leaf extract, cetyl alcohol,citric acid, glycerin, glyceryl strearate SE,mineral oil, PEG-100 stearate,phenoxy-ethanol,purified water, stearyl alcohol,vitamin E, white petrolatum, xanthan gum.
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