SPL v1
SPL
SPL Set ID d809908d-6ae2-48f2-8325-50d2983ca2ec
Route
TOPICAL
Published
Effective Date 2010-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 1)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-03-29

Description

Menthol 5%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

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

Dosage and 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

Description

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

Section 44425-7

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

Section 50565-1

Keep out of reach of children.  If swallowed get medical help or contact a poison control center right away.

Section 50566-9

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

Section 50567-7

When using this product:

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

Section 50569-3

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

Section 50570-1

Do not use:

  • on wounds or damaged skin
  • with a heading pad

Section 51727-6

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

Section 51945-4

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






Section 53413-1

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

Section 53414-9

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

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol 5%


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

For external use only.

Description (34089-3)

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

Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed get medical help or contact a poison control center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product:

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not use:

  • on wounds or damaged skin
  • with a heading pad

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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






Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol 5%


Advanced Ingredient Data


Raw Label Data

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