Otc - Active Ingredient
Lidocaine 5%
Treatonic 5% Lidocaine Cream
FDA Label NDC 85569-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by 100 Karma Inc for the product Treatonic 5% Lidocaine Cream (NDC 85569-014). 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 otc - active ingredient, otc - purpose, dosage & administration, warnings, otc - when using, otc - ask doctor/pharmacist, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Local Anorectal
(hemorrhoidal) Anesthetic
Dosage & Administration
For the temporary relief of local itching and discomfort associated withe anorectal disorders.
For the temporary relief of pain, burning and soreness.
Warnings
For external use only
Otc - When Using
- IF condition worsens or does not improve within 7 days, consult a doctor.
- Do not exceed the recommended daily dosage unless directed by a doctor.
- In case of bleeding, consult a doctor promptly.
- Do no t put this product into the rectum by using fingers or any mechanical device or applicatior.
Otc - Ask Doctor/Pharmacist
- An allergic reaction occurs
- Symptom does not improve or if redness, irritation, swelling, pain or other symptom develop or increase.
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
- Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, Gently dry by patting o rblotting with toilet tissue or a soft clothbefore application of this product.
- Apply to the affected area up to 6 times daily.
- Chlldren under 12 years of age: consulta doctor.
Other Safety Information
Store at room temperature 59°- 86°F (15°-30°C). Keep away from direct sunlight or heat.
Inactive Ingredient
Water, Arnica Montana Flower Extract, Emu Oil,Lecithin, Propylene Glycol, Tocopheryl Acetate,Carbomer, Menthol, Benzyl Alcohol.
Otc - Questions
Contact us at [email protected]
Tel: +1 (917)-539-7295
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