Otc - Active Ingredient
Lidocaine HCl 4%
Gnp Lidocaine Cream
FDA Label NDC 46122-614
13 label sections · Submitted to the FDA by Amerisource Bergen · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Gnp Lidocaine (NDC 46122-614). 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, when using this product, 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
Topical analgesic
Indications & Usage
temporarily relieves pain
Warnings
For external use only
Otc - Do Not Use
Do not use in large quantities, particularly over raw surfaces or blistered areas
When Using This Product
When using this product do not get into eyes
Otc - Stop Use
Stop use and ask a doctor if
- condition gets worse
- symptoms last for more than 7 days
- symptoms clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
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 over: apply to affected area not more than 3 to 4 times daily
- children under 2 years: do not use, consult a doctor
Other Information
store between 20 °C and 25 °C (68 °F and 77 °F)
Inactive Ingredient
acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, aminomethyl propanol,
C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl monostearate, methylparaben, purified water, SD alcohol 40, steareth-21
Recent Major Changes
Updated Indication and Usage section to say: temporarily relieves pain. To better align with Aspercreme 3/2026.
Directions- Changed children under 2 year: do not use to children under 2 years: do not use, consult a doctor.
Package Label.Principal Display Panel
Good Neighbor Pharmacy
Compares to Asperceme active ingredient
Lidocaine Pain Relieving Crème
Lidocaine HCL 4% - Topical Analgesic
Net Wt 2.7 oz (76.5g)
Lidocaine Carton (68 291 27v3.0)
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