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Drug Facts
Distributed By: Stratus Pharmaceuticals, Inc.,Miami, FL 33186
Lidocaine Cream
FDA Label NDC 58980-823
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Stratus Pharmaceuticals Inc for the product Lidocaine (NDC 58980-823). 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 other, active ingredient, purpose, uses, warnings, otc - 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
Active Ingredient
Lidocaine 5% w/w
Purpose
Local anesthetic
Uses
Helps relieve the pain, itching, and burning associated with other rectal disorders.
Warnings
"Methemoglobinemia Warning" use of this product may cause; a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used the product before. Stop use and seek immediate medical attention if the following develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy. If pregnant or breast feeding, ask a health provider before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of of children. If swallowed, get medical help or contact Poison Control Center immediately.
Directions
When practical, clean 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. To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.
Other Information
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Inactive Ingredients
acrylamide, allantoin, aloe vera extract, benzyl alcohol, C12-15 alkyl benzoate, carbomer, isohexadecane, polysorbate 80, propylene glycol, purified water, sodium acryloyldimethyl taurate, sodium laureth sulfate, soy lecithin and tocopheryl acetate.
Principal Display Panel - 28.35 Gram Tube Box
STRATUS
PHARMACEUTICALS INC
NDC 58980-823-30
Net WT. 1 oz. / 28.35 grams
LIDOCAINE CREAM
5%
ANORECTAL CREAM
Principal Display Panel (28.35 gram Tube Box)
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