Cvs Ultra Strength Pain Relieving
FDA Label NDC 59779-476

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 Ultra Strength Pain Relieving (NDC 59779-476). 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 drug facts, 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

Drug Facts

Active ingredient                                                    Purpose

Menthol 5%                                                             Topical Analgesic

Otc - Purpose

Uses Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • 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
  • symptoms persist for 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

  • open pouch and remove patch if desired, cut patch to size, peel off protective backing and apply sticky side to affected area
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a doctor

Storage And Handling

Other information

  • store between 20° and 25° C (68° and 77°F)

Inactive Ingredient

Inactive ingredients butylated hydroxytoluene, carboxymethylcellulose sodium, caster oil, concentrated glycerin, EDTA-2Na, gelatin, isopropyl myristate, kaolin, magnesium aluminium hydroxide, methylparaben, polyacrylic acid, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

Dosage & Administration

Distributed By:

CVS Pharmacy, Inc.

One CVS Drive.

Woonsocket, RI 02895

Made in Korea

Package Label.Principal Display Panel

Image Description (402999)

Image Description (402999)

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