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| Product NDC Code | 69678-424 | ||||
|---|---|---|---|---|---|
| Drug Name | Revive 2 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 2601581 | ||||
| Application Number | part348 | ||||
| Labeler Name | EEZAWAY RELIEF INC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Menthol 2.75%
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 For Adults and Children over 12 SHAKE WELL BEFORE EACH USE • apply generously to affected area • massage into painful area until completely absorbed • You may apply 4 to 6 times a day or as needed • Children under 12 years - ask your doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Carbomer, Arnica (Helianthus Annus, Sunflower Seed Oil, Arnica Montana Flower Extract), PPG-20 Methyl Glucose Ether, Isopropyl Alcohol USP, Oleth-10, PEG-75 Lanolin, Purified Water, Sodium Thiosulfate Pentahydrate, Tincture of Iodine.
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 temporarily relieves minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises • cramps
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Revive 2 Menthol MENTHOL, UNSPECIFIED FORM MENTHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE ARNICA MONTANA FLOWER SUNFLOWER OIL PPG-20 METHYL GLUCOSE ETHER ISOPROPYL ALCOHOL OLETH-10 PEG-75 LANOLIN WATER SODIUM THIOSULFATE IODINE
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.Packaging Label
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
Sport Pain Relief Roll-on ARNICA + COOLING MENTHOL R 2 Temporary relief of minor pain associated with ARTHRITIS, MUSCULAR ACHES, STRAINS, SORENESS AND BACKACHE MADE IN USA Manufactured For: Revive 1, LLC Incline Village, NV 89451 www.revive1.net 877-577-2289
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.
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 When using this product • use only as directed • do not bandage tightly or use with heating pad • avoid contact with eyes and mucous membranes • do not apply to wounds or damaged, broken or irritated skin • a transient burning sensation or redness may occur upon application but generally disappears in several days • if severe burning sensation occurs, discontinue use immediately • do not expose the area treated with product to heat or direct sunlight 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 Flammable • keep away from fire or flame 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