Extra Strength

Manufacturer
Saje Natural Business Inc.
Effective date
2025-10-24
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:40:19

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
0.68 fl oz (20 ml)

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

Extra Strength 20 ml and 45 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

45 ml box45 ml box45 ml45 mlExtra Strength 20 ml artworkExtra Strength 20 ml artwork

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-023-01Extra Strength1 in 1 BOXOIL18
70983-023-01Extra Strength45 mL in 1 BOTTLE, WITH APPLICATOROIL458
70983-023-02Extra Strength20 mL in 1 BOTTLE, WITH APPLICATOROIL208

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
70983-02370983-023-02, 70983-023-01

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72023-10-05full-release2026-05-31 23:56:27

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 SALICYLATESaje Natural Business Inc.87d872b3-3231-d0f2-e053-2995a90a9d982025-10-24WarningsExact identifier
ndc (package): 70983-023-02
ndc (package): 70983-023-01
ndc (product): 70983-023
ndc11 (package): 70983002301
ndc11 (package): 70983002302
spl id: 41ee90e0-d371-d1e7-e063-6394a90a42e3
spl set id: 87d872b3-3231-d0f2-e053-2995a90a9d98

Reported adverse events (FAERS/openFDA)#

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