Personal Care Extra Strength Cold Hot
FDA Label NDC 29500-9083

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Personal Care Products, Llc for the product Personal Care Extra Strength Cold Hot (NDC 29500-9083). 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 - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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