Asperflex Original Maximum Strength Patch
FDA Label NDC 71399-4461

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Akron Pharma Inc. for the product Asperflex Original Maximum Strength (NDC 71399-4461). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Menthol 7.5%

Purpose

Topical analgesic

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with:

■ arthritis ■ simple backache ■ strains ■ sprains ■ bruises

Warnings

For external use only

Do Not Use

■ on wounds, damaged, broken or irritated skin

■ with a heating pad or apply local heat to the area of use

When Using This Product

  • use only as directed. Read and follow all directions and warnings on this carton.
  • do not allow contact with
  • the eyes and mucous membranes
  • rare cases of serious burns have been reported with products of this type
  • do not apply to wounds or damaged, broken or irritated skin
  • do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
  • do not use at the same time as other topical analgesics
  • a transient burning sensation may occur upon application but generally disappears in several days
  • avoid applying into skin folds <do not use more than 4 patches at a time

Stop Use And Ask A Doctor If

condition worsens or symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

■ severe burning sensation, redness or irritation develop

■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

adults and children 12 years of age and older:

■ gently fold the patch in half to remove center section of film backing. Apply the exposed adhesive portion to the site of pain.

■ remove remaining film backing from both sides and finish applying to skin

■ apply to affected area not more than 3 to 4 times daily

children under 12 years of age: consult a doctor

Other Information

store at room temperature 15°-30°C (59°-86°F).

Inactive Ingredients

aluminum glycinate, propylene glycol, sodium acrylate/sodium acryloyldimethyl taurate copolymer, tartaric acid, 2,4-Imidazolidinedione, disodium edta, water, glycerin

Questions Or Comments?

Call toll-free 1-877-255-6999.

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