Otc - Active Ingredient
Active Ingredients
Lidocaine 2.00 %
Assured Cream
FDA Label NDC 55621-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhejiang Jingwei Pharmaceutical Co., Ltd. for the product Assured (NDC 55621-011). 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
Purpose
Topical analgesic
Indications & Usage
Uses temporarily relieves pain, itching and irritation.
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use
-before any hair removal process that involves heat or lasers
-in large quantities, particularly over raw surfaces or
blistered areas
Otc - When Using
When using this product
-avoid contact with eyes -use only as directed
Otc - Stop Use
Stop use and ask a doctor if
-symptoms persist for more than 7 days or clear up and occur
again within a few days
-condition worsens
-redness is present
-irritation develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, get
medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
adults and children over 12 years of age:
-immediately after hair removal, apply sparingly and only to the
areas where it is needed
-Repeat as necessary, but no more than 4 times daily
-Continue to apply as a regular part of your hair removal routine,
whether you use a razor, wax or depilatory
Storage And Handling
Other information store at room temperature 59 - 86 F
(15 - 30 C)
Inactive Ingredient
Inactive Ingredients aloe barbadensis leaf juice, carbomer
940, ethyl alcohol, ethylparaben, glycerin, menthol, propanediol,
triethanolamine, water
Package Label.Principal Display Panel
Copy Of Label (Jingwei Label)
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