Active Ingredient
Lidocaine HCI 4%
Topcare Pain Relief Liquid
FDA Label NDC 36800-529
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 for the product Topcare Pain Relief (NDC 36800-529). 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, uses, warnings, do not use, when using this product, stop use and ask a doctor if, flammable, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical anesthetic
Uses
▪ temporarily relieves minor pain
Warnings
For external use only
Do Not Use
▪ on large areas of the body or on cut, irritated or swollen skin▪ on puncture wounds▪ for more than one week without consulting a doctor
When Using This Product
▪ use only as directed. Read and follow all directions and warnings on this carton.▪ do not allow contact with the eyes▪ do not bandage or apply local heat (such as heating pads) to the area of use
Stop Use And Ask A Doctor If
▪ condition worsens▪ symptoms persist for more than 7 days or clear up and occur again within a few days
Flammable
▪ Keep away from fire or flame
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children And Pets.
If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Directions
adults and children over 12 years:
▪ apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
children 12 years and younger: ask a doctor
Inactive Ingredients
aloe barbadensis leaf juice. Carbomer, disodium EDTA, glycerin, phenyl carbinol, purified water, sodium hydroxide.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
NDC# 36800-529-25
Compare to the active ingredient in Aspercreme® Odor Free with 4 % Lidocaine*
MAXIMUM STRENGTH
PAIN RELIEF Roll-On Liquid
Lidocaine HCl 4%
Odor Free
- Temporary relief of pain
- Helps pain-affected areas
- No-touch applicator
- Oil-Free
- Paraben-Free
- Alcohol-Free
With Aloe
NET WT 2.5 OZ (71 g)
CHILD-RESISTANT PACKAGING. CLOSE CAP TIGHTLY AFTER USE.
DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 6007
TOPCO RSE515
QUESTIONS? 1-888-423-0139
*This product is not manufactured or distributed by Chattern, Inc., owner of the registered trademark Aspercreme® Odor Free with 4% Lidocaine.
Pain Relief Roll On Lidocaine Liquid (Aspercreme With Lidocaine Pain Relieving Creme 01)
* Please review the disclaimer below.
