FDA Label for Major Extra Strength Cold And Hot Pain Relief Therapy
View Indications, Usage & Precautions
Major Extra Strength Cold And Hot Pain Relief Therapy Product Label
The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient Purpose
Menthol 5%..........................................................................Topical analgesic
Otc - Purpose
Uses
Temporarily relieves minor pain associated with:
- arthritis
- simple backache
- bursitis
- tendonitis
- muscle strains
- muscle sprains
- bruises
- cramps
Warnings
Warnings
For external use only
Otc - When Using
W hen using this product
- use only as directed
- do not bandage tightly or use with a heating pad
- avoid contact with eyes and mucous membranes
- do not apply to wounds or damaged skins
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens
- redness is present
- irritation develops
- symptoms persist for more than 7 days or clear up and occur again within a few days
Otc - Pregnancy Or Breast Feeding
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.
Indications & Usage
Directions
- adults and children 12 years:
- remove backing from patch by grasping both ends firmly and gently pulling until backing seperates in middle
- carefully remove backing from patch
- apply one patch to affected area
- wear one patch up to 8 hours
- repeat as necessary, but no more than 4 times daily
- consult a doctor
children 12 years or younger:
Storage And Handling
Other information
- store at room temperature, not to exceed 86°F (30°C)
Inactive Ingredient
Inactive ingredients 1,3-butlene glycol, aloe vera, BHT, d-sorbitol, disodium edetate, gelatin, glycerin, kaolin, liquid paraffin, magnesium aluminum hydrate, methacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, tocopherol acetate
Dosage & Administration
Distributed By:
Major Pharmaceuticals
17177 N Laurel Park Dr.
Suite 233
Livonia, MI 48150
Made in Korea
Package Label.Principal Display Panel
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