Mediflex by SAS Group Inc. / Accupack Midwest Inc. MEDIFLEX- menthol cream

Mediflex by

Drug Labeling and Warnings

Mediflex by is a Otc medication manufactured, distributed, or labeled by SAS Group Inc., Accupack Midwest Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 5%

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.

DO NOT USE

Do not use:

• on wounds or damaged skin
• with a heading pad
  

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
  

WHEN USING

When using this product:

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

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
  

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, ask a health professional before use.

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

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

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

INGREDIENTS AND APPEARANCE

MEDIFLEX 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67662-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5   in 85 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67662-001-03	85 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/29/2010

Labeler - SAS Group Inc. (948174057)

Registrant - SAS Group Inc. (948174057)

Establishment
Name	Address	ID/FEI	Business Operations
SAS Group Inc.		948174057	relabel

Establishment
Name	Address	ID/FEI	Business Operations
Accupack Midwest Inc.		139637433	manufacture