FDA.reportPublic FDA data

RESTORE™ Fast Acting Pain Cream

Manufacturer
Hope Science Inc. | Lifetech Resources LLC
Effective date
2018-03-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:00:45

Label at a glance#

ProductRESTORE Fast Acting Pain
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure11 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#

SPL UNCLASSIFIED SECTION

Drug Facts

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.

OTC - WHEN USING SECTION

  • 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.

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

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.

SPL UNCLASSIFIED SECTION

Distributed by Hope Science Inc.

PRINCIPAL DISPLAY PANEL - 4 fl oz Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Real Hope Thanks to Great Science

Hope™
Science

RESTORE™
Defeat Pain, Don't Mask It

FAST ACTING PAIN CREAM
4 fl oz

PRINCIPAL DISPLAY PANEL - 4 fl oz Jar Label
PRINCIPAL DISPLAY PANEL - 4 fl oz Jar Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130094922827487GTIN-13: 0094922827487
EAN-13: 0094922827487
GTIN-12: 094922827487
UPC-A: 094922827487
GTIN storage (14 digits): 00094922827487		restore-01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71970-301-062023-04-03C16284748780-19d75b9d0-95bc-f424-e053-dadaa90a57ceRESTORE™ Fast Acting Pain Cream
71970-301-062020-01-31C16284748780-19d75b9d0-95bc-f424-e053-dadaa90a57ceRESTORE™ Fast Acting Pain Cream

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71970-30171970-301-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
CETYL TALLOWATEMVY7P518D2IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
PEPPERMINT OILAV092KU4JHIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
.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
f8715825-64dc-c794-e053-6394a90ae0f0f44d0ce5-dc89-4f80-a585-dd875848325b2023-04-03WarningsExact identifier
spl set id: f44d0ce5-dc89-4f80-a585-dd875848325b

Reported adverse events (FAERS/openFDA)#

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