FDA.reportPublic FDA data

Coolexa

Manufacturer
Rising Pharma Holdings, Inc. | Elysium Pharmaceuticals Ltd
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:43:45

Label at a glance#

ProductCoolexa
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure10 sections

Indications and uses

temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Dosage and administration

use only as directed adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

Storage and handling

store at 20° to 25°C (68° to 77°F) Lot No. & Exp Date: See box or crimp of tube

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Camphor 4%Topical analgesic
Menthol 10%Topical analgesic
Methyl Salicylate 30%Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • with a heating pad or apply external heat
  • on a child under 12 years of age with arthritis-like conditions

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have redness over the affected area

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • use only as directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • store at 20° to 25°C (68° to 77°F)
  • Lot No. & Exp Date: See box or crimp of tube

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carbomer, disodium edetate, glyceryl stearate SE, lanolin, polysorbate 80, potassium hydroxide, stearic acid, trolamine, water.

Questions and comments?

OTC - QUESTIONS SECTION

Call 1-844-474-7464

SPL UNCLASSIFIED SECTION

CoolexaTM is a trademark owned by Rising Pharma Holdings, Inc.

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made in India
Mfg. Lic. No.: G/25/1362

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CoolexaTM

Camphor, Menthol, Methyl Salicylate

4%, 10%, 30%

Topical analgesic cream

ULTRA STRENGTH

Net Wt. 4 oz (113 g)

camp-ment-methyl-sal-label-1camp-ment-methyl-sal-label-1

camp-ment-methyl-sal-label-2camp-ment-methyl-sal-label-2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamPSN1
283083camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD1
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130357237351130GTIN-13: 0357237351130
EAN-13: 0357237351130
GTIN-12: 357237351130
UPC-A: 357237351130
GTIN storage (14 digits): 00357237351130		camp-ment-methyl-sal-label-2.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-351-13Coolexa1 in 1 CARTONCREAM11
57237-351-13Coolexa113 g in 1 TUBECREAM1131
57237-351-57Coolexa1 in 1 CARTONCREAM11
57237-351-57Coolexa57 g in 1 TUBECREAM571

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57237-35157237-351-57, 57237-351-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER0A5MM307FCIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
LANOLIN7EV65EAW6HIACT
POLYSORBATE 806OZP39ZG8HIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

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
CoolexaCAMPHOR, MENTHOL, METHYL SALICYLATERising Pharma Holdings, Inc.38839f29-d4ce-4684-a3c7-0bb4bf1ad5942025-11-06WarningsExact identifier
ndc (package): 57237-351-57
ndc (package): 57237-351-13
ndc (product): 57237-351
ndc11 (package): 57237035113
ndc11 (package): 57237035157
spl id: 9e551d98-76bc-4d63-9462-006e858528fb
spl set id: 38839f29-d4ce-4684-a3c7-0bb4bf1ad594

Reported adverse events (FAERS/openFDA)#

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