Care One Cool Heat Pain Relieving
FDA Label NDC 41520-863

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 Care One Cool Heat Pain Relieving (NDC 41520-863). 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 ingredients                                                                                     Purpose

Menthol 10%............................................................................................Topical Analgesic

Methyl Salicylate 30%...............................................................................Topical Analgesic

Otc - Purpose

Uses

temporarily relieves minor pain associated with

  • Arthritis
  • Simple backache
  • Muscle strains
  • Sprains
  • Bruises
  • Cramps

Warnings

Warning

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Otc - When Using

When using this product

  • Use only as directed
  • Do not bandage tightly or sue with a heating pad
  • Avoid contact with eyes or mucous membranes
  • Do not apply to wounds, damaged, broken or irritated skin

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • 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.  In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Indications & Usage

Directions Adults and children over 12 years

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary but no more than 4 times daily
  • close cap tightly after use
  • keep carton as it contains important information
    • Children 12 years or younger: Ask a doctor

Inactive Ingredient

Inactive ingredients

Carbomer, Cetyl Esters, Emulsifying Wax, Oleth-3 phosphate, Stearic Acid, Triethanolamine, Water

Dosage & Administration

DISTRIBUTED BY: AMERICAN SALES COMPANY

4201 WALDEN AVENUE, LANCASTER, NY 14086

www.care1.info

Made in Korea

Package Label.Principal Display Panel

Image Of Carton Label (Careonecoolheatcream)

Image Of Carton Label (Careonecoolheatcream)

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