Otc - Active Ingredient
Lidocaine HCl 4%
Topcare Pain Relieving Cream
FDA Label NDC 76162-291
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Topcare Pain Relieving Cream (NDC 76162-291). 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, indications & usage, otc - purpose, warnings, otc - do not use, stop use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
temporarily relieves minor pain
Otc - Purpose
Topical analgesic
Warnings
For external use only
Otc - Do Not Use
In large quantities, particularly over raw surfaces or blistered areas
Stop Use
- condition gets worse
- symptoms last for more than 7 days
- symptoms clear up and occur again within a few days
Otc - When Using
do not get into eyes
Otc - Stop Use
- 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
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 at controlled room temperature 20°-25°C (68°-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
uses:
added temporarily relieves pain.
Directions
Added the required directions
Package Label.Principal Display Panel
TopCare Health
Fragrance-free
Pain Relieving Cream
with Lidocaine HCl 4% Topical Analgesic
Maximum Strength
Temporary Relief of Pain
Non-Greasy
Fast Acting
with Aloe
Net Wt 2.7oz (76.5g)
* Please review the disclaimer below.
