FDA.reportPublic FDA data

EFAC Pain Relieving Cream

Manufacturer
Hope Science Inc. | Lifetech Resources LLC
Effective date
2018-03-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:00:39

Label at a glance#

ProductEFAC Pain Relieving
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Dosage and administration

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.

Storage and handling

Store in a cool, dry place.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol (1.25%)

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Indications

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

  • 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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Store in a cool, dry place.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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.

SPL UNCLASSIFIED SECTION

Distributed by Hope Science Inc.

PRINCIPAL DISPLAY PANEL - 16 oz. Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FEEL the Difference!

Clinically Tested MORE Effective

EFAC

PAIN Relieving Cream
TOPICAL ANALGESIC

16 oz.

Maximum Absorption!

PRINCIPAL DISPLAY PANEL - 16 oz. Bottle Label
PRINCIPAL DISPLAY PANEL - 16 oz. Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71970-302-452023-03-21C16284748780-19d75b9d0-3d72-f424-e053-dadaa90a57ceEFAC Pain Relieving Cream
71970-302-492023-03-21C16284748780-19d75b9d0-3d72-f424-e053-dadaa90a57ceEFAC Pain Relieving Cream
71970-302-452020-01-31C16284748780-19d75b9d0-3d72-f424-e053-dadaa90a57ceEFAC Pain Relieving Cream
71970-302-492020-01-31C16284748780-19d75b9d0-3d72-f424-e053-dadaa90a57ceEFAC Pain Relieving Cream

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71970-30271970-302-45, 71970-302-49

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLPARABEN3QPI1U3FV8IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
CETYL TALLOWATEMVY7P518D2IACT
ETHYLPARABEN14255EXE39IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOBUTYLPARABEN0QQJ25X58GIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
METHYLPARABENA2I8C7HI9TIACT
OLIVE OIL6UYK2W1W1EIACT
PEG-100 STEARATEYD01N1999RIACT
PEPPERMINT OILAV092KU4JHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
PROPYLPARABENZ8IX2SC1OHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f76e90b0-1cbb-12f8-e053-6394a90a89ee781ae47d-91c5-4b36-8b53-f8b895efe9c52023-03-21WarningsExact identifier
spl set id: 781ae47d-91c5-4b36-8b53-f8b895efe9c5

Reported adverse events (FAERS/openFDA)#

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