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| Product NDC Code | 69204-027 | ||||
|---|---|---|---|---|---|
| Drug Name | Extra strength |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OIL | ||||
| Application Number | part348 | ||||
| Labeler Name | NATURES FORMULAE HEALTH PRODUCTS LTD. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Menthol 10.5%, Methyl Salicylate 13.4%
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Extra Strength Pain Relieving Oil Blend 1.5 fl oz (45 ml)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Adults: apply to affected area no more than 3 to 4 times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.For the temporary relief of minor aches and pains of muscles and joints associated with: • simple back ache • arthritis • strains • bruise • sprains
Purpose
Information about the drug product’s indications for use.External analgesic (Counterirritant)
Spl product data elements
Usually a list of ingredients in a drug product.Extra Strength Menthol and Methyl Salicylate CHAMAEMELUM NOBILE KUNZEA AMBIGUA WHOLE LAVENDER OIL ORIGANUM MAJORANA ROSEMARY OIL TRIFOLIUM PRATENSE FLOWER GRAPE SEED OIL PEPPERMINT OIL PEPPERMINT BETULA LENTA BARK ELETTARIA CARDAMOMUM WHOLE MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Extra Strength USA Artwork_Box 2022-01-03 Extra Strength USA Artwork_Box
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If product swallowed, get medical help or contact a Poison Control Centre right way.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.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
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.Avoid contact with eyes and mucous membranes; if this happens, rinse with vegetable oil
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Store at room temperature.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.For external use only
Flammable Keep away from fire and flame
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API