FDA.reportPublic FDA data

TopCare Pain Relief

Manufacturer
TOPCO ASSOCIATES
Effective date
2025-11-11
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:43:20

Label at a glance#

ProductTopCare Pain Relief Maximum Strength
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

temporarily relieves minor pain 

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCI 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor pain 

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
Flammable

SPL UNCLASSIFIED SECTION

  • Keep away from fire or flame

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

OTHER SAFETY INFORMATION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice. Carbomer, disodium EDTA, glycerin, phenyl carbinol, purified water, sodium hydroxide.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

QUALITY GUARANTEED

This TopCare® product is laboratory tested to guarantee its highest quality.

Your total satisfaction is guaranteed.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 36800-529-25

+TopCare health ™

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 RARA0819

QUESTIONS? 1-888-423-0139

topcare@topco.com

www.topcarebrand.com

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Aspercreme® Odor Free with 4% Lidocaine.

TopCare Health Maximum Strength Pain Relief Roll-On-Liquid
TopCare Health Maximum Strength Pain Relief Roll-On-Liquid

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1987647lidocaine hydrochloride 4 % Topical SolutionPSN8
1987647lidocaine hydrochloride 40 MG/ML Topical SolutionSCD8
1987647lidocaine hydrochloride 4 % Topical SolutionSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codetopbrnds.com/48zzx5aspercreme-with-lidocaine-pain-relieving-creme-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-529-25TopCare Pain ReliefMaximum Strength1 in 1 CARTONLIQUID18
36800-529-25TopCare Pain ReliefMaximum Strength71 g in 1 BOTTLELIQUID718

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-52936800-529-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-11-06full-release2026-06-01 00:34:31

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopCare Pain Relief Maximum StrengthLIDOCAINE HYDROCHLORIDETOPCO ASSOCIATESb0ae3a7c-52d1-4923-bd50-6bb3749006c82025-11-11WarningsExact identifier
ndc (package): 36800-529-25
ndc (product): 36800-529
ndc11 (package): 36800052925
spl id: 434f7f77-b27f-62c1-e063-6394a90a3138
spl set id: b0ae3a7c-52d1-4923-bd50-6bb3749006c8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.