Careone Extra Strength Cold And Hot
FDA Label NDC 41520-871

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Sales Company for the product Careone Extra Strength Cold And Hot (NDC 41520-871). 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 - keep out of reach of children, indications & usage, storage and handling, 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

Temporarily relieves minor pain associated with:

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

Warnings

Warnings

For external use only

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
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poision Control Center right away

Indications & Usage

Directions

adults and children over 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

    • children 12 years or younger: consult a doctor

Storage And Handling

Other information

  • store at room temperature, not to exceed 86°F (30°C)

Inactive Ingredient

Inactive ingredients

alove vera, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate,  methylparaben, polyethylene glycol monostearate, polysorbate 80, polyvinyl alcohol, polyvinyl pyrrolidone, purified water, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate. Release Liner: polypropylene, non-woven material: polyester non-waven fabric

Dosage & Administration

Distributed by:

Foodhold U.S.A., LLC

Landover, MD 20785

Made in Korea

Package Label.Principal Display Panel

Image Description (87180.1)

Image Description (87180.1)

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