Active Ingredient
Lidocaine 4%
Oheal Tattoo Numbing Cream
FDA Label NDC 84746-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shandong Yuyaotang Pharmaceutical Co., Ltd for the product Oheal Tattoo Numbing Cream (NDC 84746-005). 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.
Label Section Quick Index
Purpose
Local Anesthetic
Use
For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal
area associated with anorectal disorders.
Warnings
For External Use Only
●Pregnant or breastfeeding, ask a health professional before use.
●In case of accidental overdose, contact a doctor or Poison Control Center immediately.
●Seal is broken or missing.
Do Not Use
●Pregnant or breastfeeding, ask a health professional before use.
●In case of accidental overdose, contact a doctor or Poison Control Center immediately.
●Seal is broken or missing.
When Using
●Do not exceed the recommended daily dosage unless directed by a doctor.
●Certain persons can develop allergic reactions to ingredients in this product.
●Do not put this product into the rectum by using fingers or any medical device or applicator.
Stop Use
The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.
Ask Doctor
The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.
Keep Oot Of Reach Of Children
In case of accidental ingestion, seek medical attention immediately.
Directions
1. Before the cream’s application, wash hands thoroughly and wear disposable tattoo gloves.
2. Clean the area of the body receiving the tattoo. Dry completely.
3. Apply a thick amount of numbing cream to the cleaned area and rub in thoroughly, Cover with plastic wrap.
4. Leave cream and wrap in place for 30-45 minutes. Wipe the cream away and clean the area thoroughly, ready for your pain free tattoo.
Other Information
●Keep away from direct sunlight or heat
●Store in room temperature (59-860F / 15-300C)
Inactive Ingredients
Glycerin, Butylene Glycol, Xanthan Gum, Sodium Hyaluronate, Butyrospermum Parkii (Shea Butter) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Dimethicone, Glyceryl Stearate, Cetearyl Glucoside, Cetearyl Alcohol, Tocopherol, Menthol, Borneol
Questions
www.ohealpro.com
[email protected]
669-588-4076
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