Otc - Active Ingredient
LIDOCAINE 4%
Numbing Cream
FDA Label NDC 87278-022
11 label sections · Submitted to the FDA by Guangxi Keyun E-commerce Co., Ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangxi Keyun E-commerce Co., Ltd. for the product Numbing Cream (NDC 87278-022). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, 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 Anesthetic
Indications & Usage
Temporarily relieves pain and itching due to : minor burns,sunburn, insect bites, scrapes,minor skin irritations.
Warnings
For external use only
Otc - Do Not Use
Preganant or breastfeeding.ask a health professional before use.
If there is any allergic reaction tos.
In case of accidental overdose,get medical help, or contact the poison control center immediately.
Otc - When Using
Do not exceed the recommended daily dosage unless directed by a doctor.
Some individuals may experience allergic reactions to the ingredients contained in this product.
Do not insert this product into the rectum using fingers or any mechanical device or applicator.If the condition worsens or does not improve within 7 days,consult a doctor.
Otc - Stop Use
If discomfort persists for 7 days.
Certain persons may develop allergic reactions to ingredients in this product. If redness,irritation, swelling, pain, or other symptoms occur or worsen,discontinue use and consult a doctor.
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion,seek medical help immediately.
Dosage & Administration
Clean the skin.
Apply an appropriate amount of this product evenly to the tattoo area and gently massage to promote its absorption.
Inactive Ingredient
ARNICA MONTANA FLOWER EXTRACT
EMU OIL
1,2-HEXANEDIOL
CARBOMER
ARGININE
MINERAL OIL
GLYCERIN
GLYCERYL STEARATE
AQUA
Package Label.Principal Display Panel
Label1 (Label)
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