FDA.reportPublic FDA data

Trauma Less Topical Analgesic Ointment

Manufacturer
Natures Formulae Health Products Ltd.
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:29:18

Label at a glance#

ProductTrauma Less
Active ingredientMENTHOL
Label structure16 sections

Dosage and administration

Adults and children 12 years of age and older: Apply to affected area 

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP THIS PACKAGE FOR FULL INFORMATION.

DRUG FACTS Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.27%

OTC - PURPOSE SECTION

Purpose Topical Analgesic

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

Warnings

WARNINGS SECTION

For external use only.

Flammable: Keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • if allergic to plants of the asteraceae/compositae/daisy family.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • 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. 

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a doctor before use.

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INDICATIONS & USAGE SECTION

  • Adults and children 12 years of age and older: Apply to affected area 

DOSAGE & ADMINISTRATION SECTION

      not more than 3 times daily.

  • Not recommended for children under 12 years of age.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Arnica montana flower extract, beeswax (yellow), olive oil, and peppermint oil.

Questions?

OTC - QUESTIONS SECTION

1-877-275-7253

SPL UNCLASSIFIED SECTION

Distributed by: SAJE NATURAL WELLNESS 500-88 E. Pender St. Vancouver, BC Canada V6A 3X3 | saje.com | 1-877-275-7253 | Made by our friends in Canada

DO NOT USE IF SECURITY SEAL AROUND TIN IS BROKEN OR MISSING.

SKU 435301

Lift Here

DISPOSAL AND WASTE HANDLING

We support recycling.  Please recycle where possible. 

Trauma Less Topical Analgesic Ointment

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Saje® Natural Wellness

Trauma Less

Topical Analgesic Ointment

net wt. 1.91 oz | 54.1 g and net wt. 0.47 oz | 13.5 g Trauma less 13.5 gTrauma less 13.5 g

Trauma Less 54.1 g BOXTrauma Less 54.1 g BOX

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1813422menthol 1.27 % Topical OintmentPSN2
1813422menthol 0.0127 MG/MG Topical OintmentSCD2
1813422menthol 1.27 % Topical OintmentSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69204-010-01Trauma Less54.1 g in 1 CANISTEROINTMENT54.12
69204-010-01Trauma Less1 in 1 BOXOINTMENT12
69204-010-02Trauma Less13.5 g in 1 CANISTEROINTMENT13.52

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69204-01069204-010-01, 69204-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
YELLOW WAX2ZA36H0S2VIACT
OLIVE OIL6UYK2W1W1EIACT
PEPPERMINT OILAV092KU4JHIACT
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
Trauma LessMENTHOLNatures Formulae Health Products Ltd.781e94d5-1d34-7202-e053-2991aa0ae7682025-12-29WarningsExact identifier
ndc (package): 69204-010-02
ndc (package): 69204-010-01
ndc (product): 69204-010
ndc11 (package): 69204001002
ndc11 (package): 69204001001
spl id: 471f8b22-6a8c-3ca3-e063-6294a90a5241
spl set id: 781e94d5-1d34-7202-e053-2991aa0ae768

Reported adverse events (FAERS/openFDA)#

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