PlayMakar Roll-On Cool Pain Relief Gel

Manufacturer
PlayMakar Inc.
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:59:03

Label at a glance#

ProductPlayMakar Roll On Cool Pain Relief
Active ingredientMENTHOL
Label structure7 sections

Dosage and administration

Adults and children two-years of age or older: Apply to affected area not more than three to four times dail Children under two-years of age: consult a physician

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 6%

OTC - PURPOSE SECTION

Topical Analgesic

Indications:

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises, and strains.

Warnings

WARNINGS SECTION

For external use only

  • Avoid contact with eyes
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, consult physician

Do not apply

OTC - DO NOT USE SECTION

  • to wounds or damaged skin
  • Do not bandage tightly

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

contact physician prior to use

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children two-years of age or older: Apply to affected area not more than three to four times dail
  • Children under two-years of age: consult a physician

Other information

SPL UNCLASSIFIED SECTION

store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arctium Lappa (Burdock) Root Extract, Arnica Montana Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis (Yerba Mate’) Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Extract, Phenoxyethanol, Polysorbate- 20,  Tocopheryl Acetate (Vitamin E), Triethanolamine

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UL2023UL2023

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415976menthol 6 % Topical GelPSN4
415976menthol 0.06 MG/MG Topical GelSCD4
415976menthol 6 % Topical GelSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72909-015-01PlayMakar Roll On Cool Pain Relief88 mL in 1 BOTTLEGEL884

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72909-015PLAYMAKAR ROLL ON COOL PAIN RELIEF (MENTHOL) GEL [PLAYMAKAR INC.]4Current NDC, Legacy NDC, 1 package rows20231106_a12c16e7-561f-45a7-93c6-34d693ffdc7c.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72909-01572909-015-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

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
PlayMakar Roll On Cool Pain ReliefMENTHOLPlayMakar Inc.a12c16e7-561f-45a7-93c6-34d693ffdc7c2023-11-05WarningsExact identifier
ndc (package): 72909-015-01
ndc (product): 72909-015
ndc11 (package): 72909001501
spl id: 0974b923-d026-7dcc-e063-6294a90aeb1b
spl set id: a12c16e7-561f-45a7-93c6-34d693ffdc7c

Reported adverse events (FAERS/openFDA)#

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