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| Product NDC Code | 76348-711 | ||||
|---|---|---|---|---|---|
| Drug Name | Natural relief 1222 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 240896 | ||||
| Application Number | M017 | ||||
| Labeler Name | RENU LABORATORIES, INC. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Menthol. . . . 1.25 percent
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.Directions adults and children 12 years of age and older - apply liberally to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Allium Sativum (Garlic) Bulb Extract, Aloe Barbadensis (Aloe) Leaf Extract, Benzoic Acid, Collagen, Dehydroacetic Acid, Deionized Water, Emulsifying Wax NF, Fragrance, Glycine Soja (Soybean) Oil, HPUS Bryonia 10x, HPUS Rhus Toxicodendron 10x, Hydolyzed Elastin (Powder), Mineral Oil, Myristyl Myristate, Phenoxyethanol, Propylene Glycol, USP, Prunus Amygdalus Dulcis (Sweet Almond Oil), Squalane, Stearic Acid, Triethanolamine, Vitamin E dl Alpha Tocopherol
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.Temporary relief of minor aches and pains associated with arthritis simple backache muscle strains sprains bruises
Purpose
Information about the drug product’s indications for use.Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Natural Relief 1222 Menthol STEARIC ACID PHENOXYETHANOL GARLIC TOXICODENDRON PUBESCENS LEAF PROPYLENE GLYCOL MYRISTYL MYRISTATE BRYONIA ALBA ROOT SQUALANE WHITE WAX WATER TROLAMINE .ALPHA.-TOCOPHEROL HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) MARINE COLLAGEN, SOLUBLE MENTHOL MENTHOL ALMOND OIL SOYBEAN OIL ALOE VERA LEAF BENZOIC ACID DEHYDROACETIC ACID TETRASODIUM EDETATE DIHYDRATE
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.Natural Relief 1222 Label LABEL ART NR1222 bottle label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Added a better explanation of uses 1.22.2024 Directions modified for a better explanation 1.22.2024
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 If swallowed, seek medical help or contact a poison control center right away
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Store at 68 ° to 77° F.
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 persists for more than 3 days or worsens.
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.When using this product: Do not bandage tightly - avoid contact with eyes do not apply to wounds or damaged skin do not use heating pads or other heating devices
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 Avoid contact with eyes and sensitive areas. 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. Stop use and ask a doctor if condition persists for more than 3 days or worsens. Keep out of reach of children.
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