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| Product NDC Code | 72226-305 | ||||
|---|---|---|---|---|---|
| Drug Name | Gold ice pain relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 2003750 | ||||
| Application Number | M017 | ||||
| Labeler Name | Eden's Answers, Inc. | ||||
| 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.Active Ingredient Menthol 6.25% Purpose External Analgesic
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 apply to affected area not more than 3 to 4 times daily Adult and children 12 years of age and over: consult a physician Children under 12 years of age:
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingrediets Beeswax, Capsicum Frutescens Fruit Powder, Lavandula Angustifolia (Lavender) Flower Extract, Lavandulaangustifolia (lavender) Oil, Mentha Piperita (Peppermint) Leaf, Rosmarinus officinalis (Rosemary) Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Oil, Verbascum Thapsus Extract
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.Uses temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains
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.GOLD ICE Pain Relief MENTHOL YELLOW WAX TABASCO PEPPER LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER LAVENDER OIL MENTHA PIPERITA LEAF ROSEMARY ROSEMARY OIL VERBASCUM THAPSUS WHOLE MENTHOL MENTHOL
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.Package Labeling: Label4 Label5
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information close container tightly and store at room temperature do not use if plastic seal around cap is broken or missing store in a cool, dry place
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 swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? Sprigs Life Inc PO Box 387 Millersburg, Ohio 44654 1-888-990-7763 Mon-Fri 8am-3pm EST
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 symptoms persist for more than 7 days or clears up and occur again within a few days. redness or skin irritation occurs
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 apply to wounds or damaged skin Do not bandage tightly do not use with a heating pad avoid contact with the eyes or mucous membranes use only as directed
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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: For external use only Keep away from fire or flame Flammable: When using this product do not apply to wounds or damaged skin Do not bandage tightly do not use with a heating pad avoid contact with the eyes or mucous membranes use only as directed Stop Use and ask a Doctor if condition worsens symptoms persist for more than 7 days or clears up and occur again within a few days. redness or skin irritation occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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