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  5. Label Information: Personal Care Extra Strength Cold Hot

FDA Label for Personal Care Extra Strength Cold Hot

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - WHEN USING
    5. OTC - STOP USE
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. INDICATIONS & USAGE
    9. STORAGE AND HANDLING
    10. INACTIVE INGREDIENT
    11. DOSAGE & ADMINISTRATION
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Personal Care Extra Strength Cold Hot Product Label

The following document was submitted to the FDA by the labeler of this product Personal Care Products, Llc. 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 for the temporary relief of minor aches and pains associated with:

  • simple backache
  • muscle strains
  • muscle sprains
  • cramps
  • bursitis
  • arthritis
  • bruises

Warnings



Warnings

For external use only


Otc - When Using




When using this product

  • use only as directed
  • do not apply to wounds, damaged, or sensitive skin
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes

Otc - Stop Use



Stop use and ask doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • redness is present
  • skin irritation develops

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 of age and older

  • 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
  • repeat as necessary, but not more than 3 to 4 times daily
    • children under 12 years of age consult a doctor

Storage And Handling



Other information

Store at 68o to 77oF (20o to 25oC)


Inactive Ingredient



Inactive ingredients

aloe vera, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monsterarate, polysorbate 80,

polyvinyl alcohol, polyvinyl pyrrolidone, purified water, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate (Vitamin E).


Dosage & Administration



Distributed by:

PERSONAL CARE PRODUCTS, LLC.

Bingham Farms, MI 48025-3463

Made in China


Package Label.Principal Display Panel



image of carton label - hotandcoldpatch

image of carton label - hotandcoldpatch

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