Otc - Active Ingredient
Menthol 10.5%, Methyl Salicylate 13.4%
Extra Strength Oil
FDA Label NDC 69204-027
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Natures Formulae Health Products Ltd. for the product Extra Strength (NDC 69204-027). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, flammable, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
External analgesic (Counterirritant)
Indications & Usage
For the temporary relief of minor aches and pains of muscles and joints associated with: • simple back ache • arthritis • strains • bruise • sprains
Warnings
For external use only
Flammable
Keep away from fire and flame
Otc - Do Not Use
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
Avoid contact with eyes and mucous membranes; if this happens, rinse with vegetable oil
Otc - Stop Use
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
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product swallowed, get medical help or contact a Poison Control Centre right way.
Dosage & Administration
Adults: apply to affected area no more than 3 to 4 times daily.
Storage And Handling
Store at room temperature.
Inactive Ingredient
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
Extra Strength
Pain Relieving Oil Blend
1.5 fl oz (45 ml)
Extra Strength Usa Artwork_Box
* Please review the disclaimer below.
