Active Ingredient
LIDOCAINE 5%
Lidocaine Cream
FDA Label NDC 80489-949
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ol Pharma Tech Llc. (drs. Pharmacy) for the product Lidocaine Cream (NDC 80489-949). 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 using 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
Topical anesthetic
Uses
helps relieve the pain, itching, and burning, associated with hemorrhoids and anorectal disorders.
Warnings
- use only as directed.
- Avoid contact with eyes.
- do not exceed recommended dosage unless directed by a doctor.
- do not out this product into the rectum by using fingers or any mechanical device or applicator.
Stop Using And Ask A Doctor If:
- rectal bleeding occurs.
- condition worsens or does not improve within 7 days.
- symptoms clear up and occur again within a few days.
- an allergic reaction develops to ingredients in this product.
- symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
- If pregnant or breast-feeding,ask a health professional before use.
Keep Out Of Reach Of Children
keep out of reach of children and pets.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions:
- Adult and children 12 years and over:
- children under 12 years of age: consult a doctor.
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 a soft cloth before application of this product. apply externally to the affected area up to 6 times a day
Other Information
Store between 15°-30° C (59°-30° F).
Otc - Questions
TELEPHONE NUMBER : 248 325 4231
Inactive Ingredient
water. stearic acid, vitamin E, EDTA, cetostearyl alcohol, sodium cetostearyl sulfate, trolamine, methylparaben, mineral oil, propylene glycol, propyl paraben
Package Label.Principal Display Panel
Lidocaine 5% Cream (Thumbnail Image0)
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