FDA Label for Anorectal Lidocaine Cream
View Indications, Usage & Precautions
Anorectal Lidocaine Cream Product Label
The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. 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.
Active Ingredient
Lidocaine 5% w/w
Purpose
Local anesthetic
Uses
Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.
Warnings
For external use only
When using this product
• avoid contact with eyes
• 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 increase
• symptoms clear up and return within a few days
If pregnant or breast feeding, ask a health professional before use.
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, 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.
Other Information
Store at room temperature (20-25°C) (68-77°F). Avoid excessive heat and cold. Protect from sunlight.
Inactive Ingredients
benzyl alcohol, carbomer, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, triethanolamine, vitamin E
Questions?
1-800-645-2158
Packaging
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