EFAC PAIN RELIEVING- menthol, unspecified form cream 
Hope Science Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hope Science (as PLD) - EFAC Pain Relieving Cream (71970-302) - DELIST

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

Distributed by Hope Science Inc.

PRINCIPAL DISPLAY PANEL - 16 oz. Bottle Label

FEEL the Difference!

Clinically Tested MORE Effective

EFAC

PAIN Relieving Cream
TOPICAL ANALGESIC

16 oz.

Maximum Absorption!

PRINCIPAL DISPLAY PANEL - 16 oz. Bottle Label
EFAC  PAIN RELIEVING
menthol, unspecified form cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71970-302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM12.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CETYL TALLOWATE (UNII: MVY7P518D2)  
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71970-302-45113 g in 1 JAR; Type 0: Not a Combination Product10/01/201212/31/2019
2NDC:71970-302-49454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/201712/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/201212/31/2019
Labeler - Hope Science Inc. (049917199)

Revised: 3/2023
Document Id: f76e90b0-1cbb-12f8-e053-6394a90a89ee
Set id: 781ae47d-91c5-4b36-8b53-f8b895efe9c5
Version: 2
Effective Time: 20230321
 
Hope Science Inc.