FDA.reportPublic FDA data

Ultra Strength Topical Pain Relief Cream

Manufacturer
J C UDEOZOR & SONS GLOBAL INDUSTRIES LTD
Effective date
2026-03-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:51:59

Label at a glance#

ProductUltra Strength Topical Pain Relief Cream
Active ingredientLEVOMENTHOL, METHYL SALICYLATE, CAMPHOR (NATURAL)
Label structure16 sections

Indications and uses

Temporarily relieves minor aches & pains related to: arthritis simple backaches sore muscles joint pain dislocation leg cramps bruises sprains

Label contents#

Full prescribing information#

COOLHEAT THERAPY Ultra Strength Topical Pain Relief Cream

STATEMENT OF IDENTITY SECTION

Ultra Strength Topical Pain Relief Cream

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (In each gram)

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

Purpose

OTC - PURPOSE SECTION

Active Ingredients (In each gram) ​Purpose
Camphor 4%External Analgesic
Menthol 10%External Analgesic
Methyl Salicylate 30%External Analgesic

USES

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches & pains related to:

  • arthritis
  • simple backaches
  • sore muscles
  • joint pain
  • dislocation
  • leg cramps
  • bruises
  • sprains

Warning

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any of the ingredients

Ask a doctor or pharmacist before use if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

  • sensitive skin
  • redness over the affected area

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash, itching, or excessive irritation of the skin develops
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Direction

DOSAGE & ADMINISTRATION SECTION

  • Use only as directed
  • For adults and children over 12 years, apply to the affected area 3 to 4 times daily
  • Wash hands after use
  • For Children under 12 years, consult a doctor before use

Inactive Ingredients

INACTIVE INGREDIENT SECTION


Carbomer, Disodium EDTA, Glyceryl Stearate, Lanolin,
Polysorbate 80, Potassium Hydroxide, Stearic Acid, Water

Other Information

OTHER SAFETY INFORMATION

  • Store in a cool, dry place between 20 oC to 25 oC (68 oF - 77 oF)
  • Do not use if the seal is broken
  • See cap for lot no, mfg, and exp date

Contact Info

SPL UNCLASSIFIED SECTION

Distributed by:

CGE Brands

Email:

Info@aboniki.store

Mail:

300 Delaware Ave, Suite 210 #465
Wilmington, DE 19801

USA

COOLHEAT Ultra Strength Topical Pain Relief Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COOLHEAT Ultra Strength CreamCOOLHEAT Ultra Strength Cream

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82729-006-01Ultra Strength Topical Pain Relief Cream57 g in 1 TUBECREAM571

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82729-00682729-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
LEVOMENTHOLBZ1R15MTK7ACTIB
METHYL SALICYLATELAV5U5022YACTIB
GLYCERYL 1-STEARATE258491E1RZIACT
LANOLIN7EV65EAW6HIACT
POLYSORBATE 806OZP39ZG8HIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT

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
Ultra Strength Topical Pain Relief CreamCAMPHOR, MENTHOL, METHYL SALICYLATEJ C UDEOZOR & SONS GLOBAL INDUSTRIES LTD4db9ae57-4ab4-8fe4-e063-6394a90a7e512026-03-23WarningsExact identifier
ndc (package): 82729-006-01
ndc (product): 82729-006
ndc11 (package): 82729000601
spl id: 4db9acb8-4f1d-ca46-e063-6394a90aed52
spl set id: 4db9ae57-4ab4-8fe4-e063-6394a90a7e51

Reported adverse events (FAERS/openFDA)#

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