Active Ingredient:
Lidocaine 4% w/w
Simplicity Desensitizing
FDA Label NDC 69109-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Simplicity Laser, Llc for the product Simplicity Desensitizing (NDC 69109-004). 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:, otc - when using, stop use and ask doctor if, keep out of reach of children., directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical anesthetic
Use:
temporarily relieves pain and itching due to:
- minor cuts
- minor scrapes
- sunburn
- minor skin irritations
- minor burns
- insect bites
Warnings:
For external use only.
Otc - When Using
- do not use in or near the eyes
- do not use in large quantities, particularly over raw surfaces or blistered areas
Stop Use And Ask Doctor If
- Allergic reaction occurs
- Condition worsens or does not improve within 7 days
- Symptoms clear up and return within a few days
- Redness, irritation, swelling, pain or other symptoms begin or increase
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
- Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
- Children under 2 years of age: Consult a doctor.
Other Information
Store at USP controlled room temperature 20-25 deg.C (68-77 deg.F).
Inactive Ingredients
Ag,carbomer 940, deionized water
Simplicity Desensitizing Gel, 1 Fl Oz/30Ml (69109-004-30)
Label1 (Label1)
Label2 (Label2)
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