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  5. Label Information: Cold Hot Patch

FDA Label for Cold Hot Patch

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNNING
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. INACTIVE INGREDIENTS
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cold Hot Patch Product Label

The following document was submitted to the FDA by the labeler of this product Simple Diagnostics, 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.

Active Ingredient



Menthol 5.00%.


Purpose



Topical analgesic


Use



temporarily relieves minor aches and pains of muscles and joints due to
.arthritis .simple backache .strains . sprains
.bursitis .tendonitis . Bruises . Cramps


Warnning



For external use only.
When using this product.use only as directed . avoid contact with eyes and mucous membranes. do not apply to wounds or damaged skin.do not bandage tightly or use a heating pad
Stop use and ask doctor if
.excessive redness or irritation is present
.condition worsens
.pain persist for more than 7 days
.symptoms clear up and occur again within a few days
If pregnant or breast-feeding, ask a health professional before use, keep out of reach of childeren.If swallowed, get medical help or contact a poison control center right away.


Otc - Keep Out Of Reach Of Children



keep out of reach of childeren.If swallowed, get medical help or contact a poison control center right away.


Directions



.adults and children 12 years and over: apply patch to affected area as needed but not more than 4 times daily
.children under 12 years: ask a doctor
. for easy application: grasp both ends of pad firmly, pull at both ends. Stretch pad until the backing separates.
Remove protective film while applying pad directly to site of pain.


Inactive Ingredients



Acrylic Acid,Aluminum Hydroxide,Carmellose Sodium,2 Ethylhexyl Acrylate,Glycerin,Isopropyl Myristate,Methyl Acrylate,Nonoxynol 30,
Polyacrylate,Polyacrylic Acid,Polysorbate 80,Sorbitan Sesquioleate,Starch,Talc,Tartaric Acid,Titanium Dioxide,Water


Package Label.Principal Display Panel



image description - label1

image description - label1


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