Walgreens Medicated Pain Relieving
FDA Label NDC 0363-0149

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Walgreens Medicated Pain Relieving (NDC 0363-0149). 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 - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, 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

Camphor 1.2%......................................................................................Topical Analgesic

Menthol 5.7%........................................................................................Topical Analgesic

Methyl Salicylate 6.3%...........................................................................Topical Analgesic

Otc - Purpose

Uses

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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

  • on wounds or damaged skin
  • if you are allergic to aspirin or salicylates
  • with a heating pad
  • with or at the same time as other external analgesic products

Otc - Ask Doctor

Ask a doctor before use if you are allergic to any ingredients of this product

Otc - When Using

When using this product

  • do not use otherwise than directed
  • avoid contact with the eyes, mucous membranes or rashes

Otc - Stop Use

Stop use and ask a doctor if

  • rash, itching or excessive skin irritation develops
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms 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 Poison Control Center right away.

Caution: This product contains natural rubber latex which may cause allergic reactions.

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 for 7 days
  • Remove patch from skin after at most 8 hours application
  • Children under 12 years of age: Consult a doctor



Storage And Handling

Other information

  • avoid storing product in direct sunlight
  • protect from excessive moisture

Inactive Ingredient

Inactive ingredients

Butylated Hydroxytoluene, Glyceryl Rosinate, Natural Rubber, Polybutene, Polyisobutylene, Precipitated Calcium Carbonate, Quinton, Sorbitan Stearate, Tocopherol Acetate, YS Resin, Zinc Oxide

Dosage & Administration

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

MADE IN KOREA

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