FDA.reportPublic FDA data

CU Pain Away Pain Relief

Manufacturer
Canadian Unique Health Ltd.
Effective date
2025-07-18
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:08:07

Label at a glance#

ProductCU Pain Away Pain Relief
Active ingredientMENTHOL
Label structure8 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 2 years of age and older: Apply to affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.25%

Purpose

OTC - PURPOSE SECTION

Counterirritant

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. Avoid contact with the eyes and mucous membranes.

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • irritation of the skin develops                                                                                                                                                                           If pregnant or breast-feeding, ask a health professional before use.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age: Consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Store in a cool dry place
  • Protect from heat and light

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe (Aloe barbadensis) leaf juice, avocado (Persea gratissima) oil, caprylyl glycol, cetearyl alcohol, coco-caprylate, coconut (Cocos nucifera) oil, cupric oxide, disodium EDTA, isoamyl cocoate, isopropyl palmitate, jojoba (Simmondsia chinensis) seed oil, lavender (Lavandula angustifolia) oil, lemon (Citrus limon) oil, phenoxyethanol, polysorbate 60, silk amino acids, sodium lactate, stearic acid, tea tree (Melaleuca alternifolia) leaf oil, tocopherol

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-844-893-3085 Monday through Friday, 9-5pm EST or visit www.canadianunique.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416982menthol 1.25 % Topical CreamPSN7
416982menthol 12.5 MG/ML Topical CreamSCD7
416982menthol 1.25 % Topical CreamSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71304-001-00CU Pain Away Pain Relief50 g in 1 JARCREAM507
71304-001-00CU Pain Away Pain Relief1 in 1 BOXCREAM17

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71304-00171304-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
AVOCADO OIL6VNO72PFC1IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
COCO-CAPRYLATE4828G836N6IACT
COCONUT OILQ9L0O73W7LIACT
CUPRIC OXIDEV1XJQ704R4IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ISOAMYL COCOATE14OG46E98EIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
JOJOBA OIL724GKU717MIACT
LAVENDER OILZBP1YXW0H8IACT
LEMON OILI9GRO824LLIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 60CAL22UVI4MIACT
AMINO ACIDS, SILKV0L00EX1IAIACT
SODIUM LACTATETU7HW0W0QTIACT
STEARIC ACID4ELV7Z65APIACT
TOCOPHEROLR0ZB2556P8IACT
MENTHOLL7T10EIP3AACTIB

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
53869227-ec07-6442-e063-6294a90a78434a3d65db-a12e-4f50-e054-00144ff8d46c2026-06-05WarningsExact identifier
spl set id: 4a3d65db-a12e-4f50-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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