Otc - Active Ingredient
Lidocaine HCl 4%
Good Sense Pain Relief Roll On Liquid
FDA Label NDC 50804-187
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geiss, Destin & Dunn, Inc for the product Good Sense Pain Relief Roll On (NDC 50804-187). 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, dosage & administration, indications & usage, warnings, otc - keep out of reach of children, inactive ingredient, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical anesthetic
Dosage & Administration
For the temporary relief of pain and itching due to sunburn, minor burns, insect bites, minor cuts, scrapes, and minor skin irritations.
Indications & Usage
For the temporary relief of pain
Warnings
For external use only.
Flammable. Keep away from excessive heat or open flame.
Do not use in large quantities, particularly over raw surfaces or blistered areas.
When using this product avoid contact with eyes. Rinse with water if contact occurs. Do not apply to wounds or damaged skin. Do not bandage tightly.
Stop use and ask a doctor if the condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days, and redness or irritation develops.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredient
Acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., aloe barbadensis leaf extract, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glycerin stearate, methylparaben, steareth-21, water.
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
* Please review the disclaimer below.
