FDA Label for Topcare Pain Relieving Cream
View Indications, Usage & Precautions
Topcare Pain Relieving Cream Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Lidocaine HCl 4%
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.
