Label at a glance#

ProductMediflex

Active ingredientMENTHOL

Label structure16 sections

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-877-309-8118

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use:

on wounds or damaged skin
with a heading pad

OTC - ASK DOCTOR SECTION

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 SECTION

When using this product:

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

OTC - STOP USE SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

INACTIVE INGREDIENT SECTION

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 SECTION

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

DESCRIPTION SECTION

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1039690	menthol 5 % Topical Cream	PSN	1
1039690	menthol 50 MG/ML Topical Cream	SCD	1
1039690	menthol 5 % Topical Cream	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67662-001-03	2019-10-21	C162847	48780-1	956f9ecf-bd57-621f-e053-dbdaa90a74ad	d809908d-6ae2-48f2-8325-50d2983ca2ec

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67662-001-03	Mediflex	85 g in 1 JAR	CREAM	85		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67662-001	MEDIFLEX (MENTHOL) CREAM [SAS GROUP INC.]	1	Legacy NDC, 1 package rows	20100408_d809908d-6ae2-48f2-8325-50d2983ca2ec.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Mediflex
Menthol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67662-001	67662-001-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MENTHOL	L7T10EIP3A	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
286fff75-296a-4268-be96-5b63a797ee41			d809908d-6ae2-48f2-8325-50d2983ca2ec	2010-04-07	Warnings	Exact identifier spl id: 286fff75-296a-4268-be96-5b63a797ee41 spl set id: d809908d-6ae2-48f2-8325-50d2983ca2ec

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.