Asperflex Cream
FDA Label NDC 71399-6854

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 (NDC 71399-6854). 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, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 10%

Methyl Salicylate 15 %

Purpose

External analgesic

Uses

temporary relieves the minor aches and pain of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

Do Not Use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Ask A Doctor Before Use If You Have

redness over the affected area

When Using This Product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

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

■ excessive skin irritation occurs

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:

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 20°-25°C (68°-77°F).

Close cap tightly after use.

Inactive Ingredients

citric acid, glyceryl monostearate, lanolin, methylparaben, propylene glycol, propylparaben, purified water, stearic acid, trolamine

Questions Or Comments?

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

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Cream Label (Asperflex)

Cream Label (Asperflex)

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