d809908d-6ae2-48f2-8325-50d2983ca2ec

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.

Active Ingredient

Menthol 5%

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


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Active Ingredient (55106-9)

Menthol 5%

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)