Dermedial Anti-Ouch

Manufacturer: Natures Formulae Health Products Ltd.
Effective date: 2025-08-21
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:11:21

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

Contacts and useful links#

PhoneLabel contact1-877-275-7253

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 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

Dermedial Anti-Ouch+

bump & bruice balm

Recover Faster*

Net Wt. 1.91 oz | 54.1 g and Net Wt. 0.47 oz | 13.5 g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1813422	menthol 1.27 % Topical Ointment	PSN	1
1813422	menthol 0.0127 MG/MG Topical Ointment	SCD	1
1813422	menthol 1.27 % Topical Ointment	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69204-029-01	Dermedial Anti-Ouch	54.1 g in 1 CANISTER	OINTMENT	54.1	1
69204-029-01	Dermedial Anti-Ouch	1 in 1 BOX	OINTMENT	1	1
69204-029-02	Dermedial Anti-Ouch	13.5 g in 1 CANISTER	OINTMENT	13.5	1

Products#

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

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

Dermedial Anti-Ouch
Menthol
ARNICA MONTANA FLOWER
YELLOW WAX
OLIVE OIL
PEPPERMINT OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69204-029	69204-029-01, 69204-029-02

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
Name	UNII	Kind
ARNICA MONTANA FLOWER	OZ0E5Y15PZ	IACT
YELLOW WAX	2ZA36H0S2V	IACT
OLIVE OIL	6UYK2W1W1E	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
MENTHOL	L7T10EIP3A	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dermedial Anti-Ouch	MENTHOL	Natures Formulae Health Products Ltd.	3ce29160-3964-e435-e063-6394a90abb38	2025-08-21	Warnings	Exact identifier ndc (package): 69204-029-02 ndc (package): 69204-029-01 ndc (product): 69204-029 ndc11 (package): 69204002901 ndc11 (package): 69204002902 spl id: 3ce290d6-8818-87a4-e063-6294a90a74d2 spl set id: 3ce29160-3964-e435-e063-6394a90abb38

Reported adverse events (FAERS/openFDA)#

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