Revive 2
FDA Label NDC 69678-424
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eezaway Relief Inc for the product Revive 2 (NDC 69678-424). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient:, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient:
Menthol 2.75%
Purpose
Topical Analgesic
Uses
temporarily relieves minor pain associated with:
• arthritis • simple backache • muscle strains • sprains • bruises • cramps
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 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.
Packaging
Label (69678424 1)
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