EFAC PAIN RELIEVING- menthol cream

EFAC by

Drug Labeling and Warnings

EFAC by is a Otc medication manufactured, distributed, or labeled by Imagenetix, Lifetech Resources, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredients

Menthol (1.25%)

Purpose

Topical Analgesic

Indications

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

Warnings

• For external use only.
  

   

• Avoid contact with eyes.

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of product and consult a physician.

• Do not apply to wounds or damaged skin.

• Do not bandage tightly.

• Keep out of reach of children.

   

• If swallowed, get medical help or contact a poison control center right away.

Directions

Adults and children 2 yrs. of age and older, apply to affected area not more than 3 to 4 times a day. Children under 2 yrs. of age, consult a physician.

Other Information

Store in a cool, dry place.

Inactive Ingredients

Benzyl Alcohol, Butylparaben, Carbomer, Esterified Fatty Acids (Proprietary Blend), Ethylparaben, Glycerin, Glyceryl Stearate, Isobutylparaben, Lecithin, Methylparaben, Olea Europaea (Olive) Fruit Oil, PEG-100 Stearate, Peppermint Oil, Phenoxyethanol, Potassium Hydroxide, Propylparaben, Tocopheryl Acetate, Water.

Questions?

1-866-628-8725
www.HopeScience.com

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Distributed by Hope Science Inc.

PRINCIPAL DISPLAY PANEL - 113G Jar Label

Clinically
Tested MORE
Effective

TOPICAL
ANALGESIC

Esterified Fatty Acid Complex

EFAC
Pain Relieving
Cream

FEEL the Difference!

4 OZ. (113G)
MAXIMUM ABSORPTION

INGREDIENTS AND APPEARANCE

EFAC   PAIN RELIEVING
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55722-419
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	12.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
METHYLPARABEN (UNII: A2I8C7HI9T)
OLIVE OIL (UNII: 6UYK2W1W1E)
PEG-100 STEARATE (UNII: YD01N1999R)
PEPPERMINT OIL (UNII: AV092KU4JH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55722-419-02	113 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/01/2012

Labeler - Imagenetix (091209341)

Registrant - Lifetech Resources, LLC (662559110)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources, LLC		622559110	MANUFACTURE(55722-419)