FDA Label for Assured Extra Strength Cold N Hot
View Indications, Usage & Precautions
Assured Extra Strength Cold N Hot Product Label
The following document was submitted to the FDA by the labeler of this product Greenbrier International, Inc.. 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
- If pregnant or breast-feeding, ask a health professional before use
Otc - When Using
When 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 skin
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens
- symptoms persist more than 7 days or clear up and occur again within a few days
- redness is present
- skin irritation develops
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 of age and older: apply to affected area not more than 3 to 4 times daily
- Children under 12 years of age: do not use, consult a doctor
- For easy application: partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesion.
Inactive Ingredient
Inactive ingredients aloe vera, aluminum hydroxide, disodium EDTA, gelatin, kaolin, methacrylic acid copolymer, methylparaben, polysorbate 80, sorbitan monooleate, sorbitol solution, tartaric acid, titanium dioxide, tocopheryl acetate (vitamin E), water
Dosage & Administration
Distributed by:
Greenbrier International, Inc.
500 Volvo Parkway
Chesapeake, VA 23320
Made in Korea
Package Label.Principal Display Panel
* Please review the disclaimer below.