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Product NDC Code | 70994-102 | ||||||||||
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Drug Name | Pain relief |
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Type | Brand | ||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||
Dosage Form | SALVE | ||||||||||
Labeler Name | Spry Life LLC | ||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.OTC Active Ingredients Organic Arnica montana (Arnica) 1X (HPUS)
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.Dosage & Administration Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Organic Olea Europaea (Olive) Fruit Oil, Organic Cera Alba (Beeswax), Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Menthol, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Zingiber Officinale (Ginger) Root Oil, Cinnamomum Zeylanicum Bark (Cinnamon) 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.Indications & Usage ■ temporarily reief of minor aches and pains of muscles and joints associated with ■ arthritis ■ bruises ■ sprains ■ scrapes ■ strains ■ simple backache ■ sore muscles
Purpose
Information about the drug product’s indications for use.Purpose External Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Pain Relief Arnica, Menthol Crystals, Cinnamon, Peppermint, Ginger, Rosemary OLIVE OIL YELLOW WAX SUNFLOWER OIL MENTHOL ROSEMARY OIL CINNAMON OIL GINGER OIL MENTHA PIPERITA ARNICA MONTANA FLOWER ARNICA MONTANA FLOWER
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.Principal Display Panel Pain Relief Principal Panel-Back
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 Keep Out of Reach of Children.
Storage and handling
Information about safe storage and handling of the drug product.Storage and Handling 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.Warnings Warnings For external use only. ■ Avoid contact with eyes. ■ Do not use on ■ on deep wounds ■ animal bites ■ serious burns ■ Stop use and ask a doctor if ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days
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