EFAC PAIN RELIEVING CREAM- menthol, unspecified form cream

EFAC by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Caprylyl Glycol, Citric Acid, Esterified Fatty Acids (EFAC Proprieatry Blend), Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hexylene Glycol, Lecithin, Mentha Piperita (Peppermint) Oil, PEG-100 Stearate, Phenoxyethanol, Sodium Hydroxide, Tocopheryl Acetate, Water.

Questions?

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

SPL UNCLASSIFIED SECTION

Distributed by Hope Science Inc.

PRINCIPAL DISPLAY PANEL - 16 oz. Tube Label

FEEL the Difference!

Clinically Tested MORE Effective

EFAC

PAIN Relieving Cream
TOPICAL ANALGESIC

16 oz.

Maximum Absorption!

INGREDIENTS AND APPEARANCE

EFAC   PAIN RELIEVING CREAM
menthol, unspecified form cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71970-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	12.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CETYL TALLOWATE (UNII: MVY7P518D2)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PEPPERMINT OIL (UNII: AV092KU4JH)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71970-300-45	113 g in 1 JAR; Type 0: Not a Combination Product	03/01/2018
2	NDC: 71970-300-49	454 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	03/01/2018

Labeler - Hope Science Inc. (049917199)

Registrant - Lifetech Resources LLC (622559110)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources LLC		622559110	MANUFACTURE(71970-300)