FDA.reportPublic FDA data

TopCare Maximum Strength Pain Relieving

Manufacturer
Topco Associates LLC | Garcoa, Inc. | SV Labs Toronto Corporation
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:17:56

Label at a glance#

ProductTopCare Maximum Strength Pain Relieving Analgesic
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure11 sections

Indications and uses

for the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Dosage and administration

adults and children 12 years of age and older: apply generously to affected area massage into painful area until thoroughly absorbed into skin repeat if necessary, but not more than 3 to 4 times daily IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER. Children 12 years or younger: ask a doctor

Storage and handling

s tore at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 16%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only. Test on a small patch of skin before applying generously.

OTC - WHEN USING SECTION

When using this product

  • use only as directed
  • avoid contact with the eyes and mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pads or other heating devices
  • if redness is present, discontinue use and consult a doctor
  • if skin irritation occurs, discontinue use
  • a transient burning sensation may occur upon application but generally disappears in several days

OTC - DO NOT USE SECTION

Stop use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

SPL UNCLASSIFIED SECTION

Flammable

  • keep away from fire or flame

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and older:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat if necessary, but not more than 3 to 4 times daily
  • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

Children 12 years or younger: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., capsaicin, citric acid, glycerin, isopropyl myristate, propylene glycol, water.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 36800-894-01

TopCare
health®

COMPARE TO ICY HOT® ACTIVE INGREDIENT*

MAXIMUM STRENGTH

Cool n' Heat
Roll-On Liquid

External Analgesic
with Menthol 16%

STAIN FREE

  • Powerful, Fast &
    Effective Pain Relief
  • No-Mess Applicator
  • Keeps Hands Clean

OUR PHARMACISTS
RECOMMEND

2.5 FL OZ (74 mL)

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
866084menthol 16 % Topical SolutionPSN5
866084menthol 160 MG/ML Topical SolutionSCD5
866084menthol 16 % Topical SolutionSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-894-01TopCare Maximum Strength Pain RelievingAnalgesic1 in 1 CARTONLIQUID15
36800-894-01TopCare Maximum Strength Pain RelievingAnalgesic74 mL in 1 BOTTLE, WITH APPLICATORLIQUID745

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-89436800-894-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
Alcohol3K9958V90MIACT
CapsaicinS07O44R1ZMIACT
Citric Acid Monohydrate2968PHW8QPIACT
GlycerinPDC6A3C0OXIACT
Isopropyl Myristate0RE8K4LNJSIACT
Propylene Glycol6DC9Q167V3IACT
Water059QF0KO0RIACT

Source Document#

Source XML

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 Maximum Strength Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORMTopco Associates LLCdc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab2024-11-05WarningsExact identifier
ndc (package): 36800-894-01
ndc (product): 36800-894
ndc11 (package): 36800089401
spl id: 139ed16f-1958-417e-bf0e-4fe6f6f4ffaa
spl set id: dc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab

Reported adverse events (FAERS/openFDA)#

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