Cvs Medicated Heat 1 Ct Patch
FDA Label NDC 59779-770

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Cvs Medicated Heat 1 Ct (NDC 59779-770). 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 - do not use, otc - when using, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredient Purpose

Capsicum Extract 0.025% as Capsaicin ................. Topical Analgesic

Otc - Purpose

Uses

For temporary relief of minor aches and pains of muscles & joints associated with:

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

Warnings

Warnings

For external use only

Allergy alert:

  • do not use if you are allergic to capsicum, chili peppers, or any ingredients in this product
  • if prone to allergic reaction from aspirin or salicylates, consult a doctor before use

Otc - Do Not Use

Do not use

  • on wounds or damaged skin
  • with a heating pad

Otc - When Using

When using this product:

  • do not use otherwise than as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
  • discontinue use at least 1 hour before a beath or shower
  • do not use immediately after a bath or shower

Otc - Ask Doctor

Stop use and ask a doctor if:

  • conditions worsens, symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present or irritation or rash develops
  • a severe burning sensation occurs

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 12 years of age and over:

  • Clean and dry affected area
  • Remove patch from film
  • Apply to affected area not more than 3 to 4 times daily
  • do not wear patch for more than 8 hours
  • children under 12 years of age: consult a doctor

Storage And Handling

Other information

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive Ingredient

Inactive ingredietns

lanolin, methyl salicylate, natural rubber, peppermint oil, petrolatum, rosin, zinc oxide

Dosage & Administration

DISTRIBUTED BY:

CVS Pharmacy, Inc.

Woonsocket, RI 02895

Made in China

Package Label.Principal Display Panel

12129 (12129.1)

12129 (12129.1)

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