Mediflex
FDA Label NDC 67662-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sas Group Inc. for the product Mediflex (NDC 67662-001). 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, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Menthol 5%

Otc - Purpose

Topical Analgesic

Indications & Usage

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

Warnings

For external use only.

Otc - Do Not Use

Do not use:

  • on wounds or damaged skin
  • with a heading pad

Otc - Ask Doctor

Ask a doctor before use if you are:

  • prone to allergic reactions to salicylates, including aspirin
  • using a product on a child under 12 years of age

Otc - When Using

When using this product:

  • avoid contact with eyes and mucous membranes
  • use only as directed
  • do not bandage tightly

Otc - Stop Use

Stop use and ask a doctor if:

  • Condition worsens
  • If symptoms persist for more than 7 days or clear up and occur within a few days
  • Excessive skin irritation occurs

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.

Dosage & Administration

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 physician
  • Apply generously and massage into affected area until completely absorbed
  • Apply before and after sports or exercise to help soothe aching muscles and muscle strain
  • Repeat as needed up to four times per day

Storage And Handling

Store at 20 to 25 degrees Celsius (68 to 77 degrees F)

Inactive Ingredient

Aloe, Avocado Oil, Ceteareth-20, Cylcomethicone, Grape Seed Oil, MediFlex Relief Proprietary Herbal Extract Blend (juniper [berry], European Goldenrod [flower], Dandelion [leaf], Meadowsweet [herb], White Willow [bark], Methyl Glucose Sesquisterate, Natural Oil of Wintergreen, Phenoxyethanol Methylparaben, Shea Butter, Steareth-2, Stearath-10, Stearic Acid, Water

Otc - Questions

Questions or comments?  1-877-309-8118 Monday through Friday, 9am-5pm. 

Description

This product is manufactured exclusively for:  SAS Group, Inc., Tarrytown, NY 10591

Package Label.Principal Display Panel

Temporary Pain Relief

Mediflex Relief Cream

Temporary Relief of Minor Aches and Pains Associated with Arthritis, Simple Backache, Sprains, Bruises and Strains.

  • Soothing and medicated topical analgesic for aching joints and muscles
  • Effective for pre-exercise warm-up
  • Deep penetrating therapeutic pain relief
  • With skin moisturizing conditions aloe, shea butter, avocado, and grape seed oil
  • Contains MediFlex Relief's clinically tested herbal formula

    • Mediflex Front (Mediflexfront)

    Mediflex Front (Mediflexfront)


    Mediflex Back (Mediflexback)

    Mediflex Back (Mediflexback)


* Please review the disclaimer below.