Active Ingredient
Lidocaine 4%
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Shandian Jingling Technology Co., Ltd. for the product Tktalker Numbing (NDC 83804-113). 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, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Lidocaine 4%
Topical Anesthetic
For the temporary relief of pain, burning and soreness.
Warnings (For external use only)
●Do not bandage tightly; do not use with heating pad; do not apply to large areas or on broken/irritated skin.
●Do not this product if pregnant or breastfeeding, ask a health professional before use.
●Do not use on large areas, on puncture wounds, on damaged skin, or with heating pad,avoid contact with eyes.
●Stop use and ask a doctor if symptoms persist >7 days, worsen, or clear up and occur again within a few days.
●Do not bandage tightly; do not use with heating pad; do not apply to large areas or on broken/irritated skin.
●Do not this product if pregnant or breastfeeding, ask a health professional before use.
●Do not use on large areas, on puncture wounds, on damaged skin, or with heating pad,avoid contact with eyes.
When using this product
●Do not exceed the recommended daily dosage unless directed by a doctor.
●Children under 12 years of age; consult a doctor.
If Condition worsens, or does not improve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use.
●Stop use and ask a doctor if symptoms persist >7 days, worsen, or clear up and occur again within a few days.
●Stop use and ask a doctor if symptoms persist >7 days, worsen, or clear up and occur again within a few days.
In case of accidental ingestion, seek medical attention immediately.
●Adults and Children 12 years and older: 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 3-4 times daily.
●Keep away from direct sunlight or heat.
●Store in room temperature (59-86°F/15-30*C).
■ This package is child-resistant. Keep out of reach of children.
■ In case of accidental overdose or ingestion, call a doctor or poison control center immediately.
CORRECT USE STEPS BEFORE :
1. Clean hands and treatment area with mild soap and warm water (to open pores to help absorb numbing cream), then gently dry.
2. Apply a thick layer of about 2mm to the treated area.(Make sure the area and surroundings are white cream)
3. Wipe away residue, wait another 20-30 minutes for the numbness to peak. And begin procedure.
Notice:
Due to the difference of temperature and skin type, the durationof numbness effect will be different.Recommended to test in a small area first to ensure the bestnumbness effect.
Aloe barbadebsis leaf juice (Aloe vera), Water, Lecithin (Soybean), Propylene Glycol,Tocopheryl Acetate, Carbomer, Triethanolamine.
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