Extra Strength

Manufacturer
NATURES FORMULAE HEALTH PRODUCTS LTD.
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:45:02

Label at a glance#

ProductExtra Strength
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure16 sections

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 10.5%, Methyl Salicylate 13.4%

OTC - PURPOSE SECTION

External analgesic (Counterirritant)

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with: • simple back ache • arthritis • strains • bruise • sprains

WARNINGS SECTION

For external use only

Flammable

WARNINGS SECTION

Keep away from fire and flame

OTC - DO NOT USE SECTION

Do not use on wounds or damaged skin

Do not bandage tightly

Do not use if you are allergic to plants of the asteraceae/compositae/daisy family

OTC - WHEN USING SECTION

Avoid contact with eyes and mucous membranes; if this happens, rinse with vegetable oil

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product swallowed, get medical help or contact a Poison Control Centre right way.

DOSAGE & ADMINISTRATION SECTION

Adults: apply to affected area no more than 3 to 4 times daily.

STORAGE AND HANDLING SECTION

Store at room temperature.

INACTIVE INGREDIENT SECTION

Anthemis nobilis flower oil, elettaria cardamomum seed oil, kunzea ambigua branch/leaf/twig oil, lavender oil, origanum majorana leaf oil, rosmarinus officinalis (rosemary) leaf oil, syzygium aromaticum bud oil, vitis vinifera (grape) seed oil

OTHER SAFETY INFORMATION

Important: Read all product information before using. Keep this package for full information.
Do not use if security seal around bottle is broken or missing.
Questions? Call 1-877-275-7253

distributed by: saje natural wellness 22 east 5th ave vancouver, bc canada v5t 1g8 saje.com 1-877-ask-saje @sajewellness

DESCRIPTION SECTION

Extra Strength
Pain Relieving Oil Blend
1.5 fl oz (45 ml)

Extra Strength USA Artwork_Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2022-01-03 Extra Strength USA Artwork_Box2022-01-03 Extra Strength USA Artwork_Box

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69204-027-01Extra Strength1 in 1 BOXOIL12
69204-027-01Extra Strength45 mL in 1 BOTTLE, WITH APPLICATOROIL452

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69204-027EXTRA STRENGTH (MENTHOL AND METHYL SALICYLATE) OIL [NATURES FORMULAE HEALTH PRODUCTS LTD.]2Current NDC, Legacy NDC, 2 package rows20241220_d919b50a-5de2-1830-e053-2a95a90ab88d.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69204-02769204-027-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
Extra StrengthMENTHOL AND METHYL SALICYLATENATURES FORMULAE HEALTH PRODUCTS LTD.d919b50a-5de2-1830-e053-2a95a90ab88d2024-12-17WarningsExact identifier
ndc (package): 69204-027-01
ndc (product): 69204-027
ndc11 (package): 69204002701
spl id: 297f0ddf-6d38-b182-e063-6394a90a6570
spl set id: d919b50a-5de2-1830-e053-2a95a90ab88d

Reported adverse events (FAERS/openFDA)#

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