FDA Label for Large Pain Relieving

View Indications, Usage & Precautions

Large Pain Relieving Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Active IngredientPurpose
Camphor 3.1% Topical Analgesic
Menthol 6.0% Topical Analgesic
Methyl Salicylate 10.0% Topical Analgesic


Inactive Ingredienthydrogenated Poly, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Petroleum, Styrene/Isoprene Copolymer




Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.


Indications & Usage



For temporary relief of minor aches and pains of muscles and joins: arthritis, simple backache, muscle strains, muscle sprains and bruises.


Warnings



For External Use Only

Allergy Alert:If prone to allergic reactions from aspirine or salicytates, consult a doctor before use.


Dosage & Administration



Adults and children over 12 years:

Clean and dry affected area. Remove patch from film, apply to affected area not more than 3-4 times a day.

Do not use for more than 8 hours.

Discard patch after use.

Reseal pouch after opening.

Children under 12 years of age, consult a physician.


If Pregnant Or Breastfeeding



ask a health professional before use.


Purpose



Topical Analgesic


When Using This Product:



■ Use only as directed ■ Avoid contact with eyes, mucous membranes or rashes ■ Do not bandage tightly ■ Do not use at the same time as other topical analgesics ■ Dispose of used patch away from children and pets. Used patches still contain the drug product which can produce serious adverse effects if a child or pet chews or ingests the patch.


Do Not Use



  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients in this product.

Stop Use And Consult A Doctor



  • If rash, itching or excessive skin irritation develops
  • If condition worsens
  • If symptoms last more than 7 days or clear up and occur again in a few days.

Storage And Care



Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.


Pain Relieving Path



DIST. BY
Walgreens Co.
200 Wilmot Rd
. Deerfield, IL 60015
www.walgreens.com

TOLL-FREE CUSTOMER CARE HELP LINE Mon–Fri, 8:30 am–4:30 pm CST 866-326-1313


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