Otc - Purpose
Backache, Arthritis, Strains, Bruises, Sprains
Max Revive Plaster Patch
FDA Label NDC 82198-0002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Big 5 Nutrition Llc for the product Max Revive Plaster (NDC 82198-0002). 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 otc - purpose, otc - active ingredient, uses, warnings, do not use, when using this product, stop use and ask doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
| Active Ingredients | Purpose |
| Menthol 4% | External Analgesic |
| Methyl Salicylate 1 % | External Analgesic |
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with: ■ arthritis ■ strains ■ bruises ■ sprains
■ simple backache
Warnings
For external use only
Do Not Use
■ on wounds ■ irritated or damaged skin ■ sensitive skin ■ with a heating pad ■ if pregnant ■ with, or as the same time as, other external analgesic products ■ if allergic to aspirin or salicylates ■ if allergic to any ingredients of this product
When Using This Product
■ avoid contact with the eyes
■ do not bandage tightly
■ do not apply to wounds or damaged skin
■ do not use more than 3 plasters a day
■ do not use 1 hour before or after bathing
Stop Use And Ask Doctor If
■ condition worsens
■ symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
■ excessive irritation of the skin develops
■ rashes, itching or redness are present
■ side effects occur.
Otc - Pregnancy Or Breast Feeding
If pregnant, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children to avoid accidental poisoning.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Otc - Do Not Use
Do not use otherwise than as directed.
Directions
■ Adults and children 12 years of age and older:clean and dry affected area. Remove plaster from the protective layer, apply to the affected area, rub the area with your hand to secure the patch.
■ Plaster will remain effective for 8 hours.
■ Avoid using the same patch on the same area for more than 2 days.
■Do not apply to area with excessive hair. Adhesive plaster may hurt skin upon removal.
Directions (Continued)
■ Wet patch with warm water before removing from skin.
■ Children under 12 years of age: Do not use or consult a doctor.
Other Information
■ Store unused patch in the pouch
■ Store at room temperature, 20 to 25°C(68 to 77°F)
Inactive Ingredients
Chinese Clematidis Root & Rhizome, Yellow wax, Momordica cochinchinensis seeds, Castor Seeds, Myrrh, Frankincense, Sesame Oil, Resin, FD&C Blue No. 2, FD&C Yellow No. 4, Zinc Oxide
Questions Or Comments
Call:1-800-617-2021
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