FDA.reportPublic FDA data

Dermedial Anti-Ouch

Manufacturer
Saje Natural Business Inc.
Effective date
2025-08-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:09:55

Label at a glance#

ProductDermedial Anti-Ouch
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

PurposeTopical Analgesic

UsesFor 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 101-19347 24th Ave. Surrey, BC Canada V3S 3S9 | saje.com | 1-877-275-7253| Made by our friends in Canada

DO NOT USE IF SECURITY SEAL IS BROKEN OR MISSING.

SKU

Lift Here

DISPOSAL AND WASTE HANDLING

We support recycling.  Please recycle where possible. 

Saje® Natural Wellness Rescue Me - Nature's First Aid Kit with Dermedial Anti-Ouch+

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Saje® Natural Wellness

Rescue Me - Nature's First Aid Kit

with

Dermedial Anti-Ouch+

Bump & Bruise Balm (Topical Analgesic)

net wt. 0.47 oz | 13.5 g

TinTin

Retail BoxRetail Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1813422menthol 1.27 % Topical OintmentPSN1
1813422menthol 0.0127 MG/MG Topical OintmentSCD1
1813422menthol 1.27 % Topical OintmentSY1

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
70983-030-01Dermedial Anti-Ouch1 in 1 BOXOINTMENT11
70983-030-01Dermedial Anti-Ouch54.1 g in 1 CANISTEROINTMENT54.11
70983-030-02Dermedial Anti-Ouch13.5 g in 1 CANISTEROINTMENT13.51

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
70983-03070983-030-01, 70983-030-02

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
Dermedial Anti-OuchMENTHOLSaje Natural Business Inc.3c194b8f-cfa5-11e3-e063-6394a90a92de2025-08-11WarningsExact identifier
ndc (package): 70983-030-02
ndc (package): 70983-030-01
ndc (product): 70983-030
ndc11 (package): 70983003001
ndc11 (package): 70983003002
spl id: 3c194ba4-f587-682c-e063-6294a90a0b9d
spl set id: 3c194b8f-cfa5-11e3-e063-6394a90a92de

Reported adverse events (FAERS/openFDA)#

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