Active Ingredients:
Lidocaine BP 5%w/w
Pantin
FDA Label NDC 81959-0001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tmt America Llc for the product Pantin (NDC 81959-0001). 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 ingredients:, purpose:, indications & usage, warning:, keep out of reach of children, directions for use:, inactive ingredients:, other infromations:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Topical Anaesthetic
Indications & Usage
Uses for temporary relief of pain and itching due to minor skin irritation . To provide topical local analgesia for superficial
dermatological procedures.
Warning:
- For External Use only.
When using this Product - Avoid contact with eyes - Do not use in large quantities, particularly over raw surfaces or blistered areas .
Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use.
Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions For Use:
Directions For Adult & Children above 12 years of Age :
· Applied Before the procedure
· Apply very thick to area and around - Once rubbed in
· apply another layer of cream to the area - Cover the area with saran-Wrap in order for it to remain thick.
For Children under 12 years of age: Consult a physician.
Inactive Ingredients:
Cetostearyl Alcohol , Ceto Macrogol 1000 , Micro Wax, Paraffin Wax, Light Liquid Paraffin, Propylene Glycol, Glycerin & Methyl Paraben
Other Infromations:
Protect this product from excessive heat and direct Sun - Please test on small area before use.
* These statements are not evaluated by Food & Drug Administration.
Principal Display Panel
Ndc 81959-0001-3 Max Stregth Fast Acting Pantin Lidocaine 5% Topical Aneasthetic Cream Tattooing- Body Piercing-laser Treatment-body Waxing 30g (Pantin 30gm Carton.)
Ndc 81959-0001-3 Max Stregth Fast Acting Pantin Lidocaine 5% Topical Aneasthetic Cream Tattooing- Body Piercing-laser Treatment-body Waxing 30g (Pantin 30gm Tube.)
* Please review the disclaimer below.
