FDA.reportPublic FDA data

Power Relief

Manufacturer
Clientele, Inc.
Effective date
2011-09-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:29:36

Label at a glance#

ProductPower Relief
Active ingredientMenthol
Label structure9 sections

Dosage and administration

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age, consult a Physician.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 2%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Indications

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains of muscles and joints associated with

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings

WARNINGS SECTION

  • For external use only.

OTC - WHEN USING SECTION

  • Avoid contact with the eyes.

OTC - ASK DOCTOR SECTION

  • 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 this product and consult a Physician.

OTC - DO NOT USE SECTION

  • Do not apply to wounds or damaged skin.
     
  • Do not bandage tightly.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older:
    apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age, consult a Physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Butylene Glycol, Aloe Barbadensis Leaf Juice, Eucalyptus Globulus Leaf Oil, Methyl Salicylate, Camphor, Mentha Piperita (Peppermint) Oil, Carbomer, Triethanolamine, Propylparaben, Methylparaben, Diazolidinyl Urea, Tetrasodium EDTA.

SPL UNCLASSIFIED SECTION

Distributed exclusively by
American Herbal Products Corp.
North Bay Village, Florida

PRINCIPAL DISPLAY PANEL - 59.1 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

POWERRELIEF™
COOLING PAIN RELIEF ROLL ON

Net wt. 2 fl.oz (59.1 ml)
MADE IN USA

Principal Display Panel - 59.1 ml Bottle Label
Principal Display Panel - 59.1 ml Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311502menthol 2 % Topical GelPSN1
311502menthol 0.02 MG/MG Topical GelSCD1
311502menthol 2 % Topical GelSY1
311502menthol 2 % topical stickSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64483-007-022019-10-29C16284748780-1960f7f55-d48d-8e05-e053-dbdaa90a074aPOWERRELIEF™ COOLING PAIN RELIEF ROLL ON

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64483-007-02Power Relief59 mL in 1 BOTTLE, WITH APPLICATORGEL591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64483-007POWER RELIEF (MENTHOL) GEL [CLIENTELE, INC.]1Legacy NDC, 1 package rows20110917_1c04696b-12ea-48c0-a853-20e0f77a6f40.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3A1
MentholACTIVE MOIETYL7T10EIP3A1
Camphor (Synthetic)INACTIVE INGREDIENT5TJD82A1ET1
Eucalyptus oilINACTIVE INGREDIENT2R04ONI6621
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64483-00764483-007-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
MentholL7T10EIP3AACTIB
Camphor (Synthetic)5TJD82A1ETIACT
Water059QF0KO0RIACT
Eucalyptus oil2R04ONI662IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Camphor (Synthetic)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
2 equally ranked IID candidates
Camphor (Synthetic)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
2 equally ranked IID candidates
Eucalyptus oilEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate

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
6e942baa-cce1-43cd-ab4a-dc24d39ac9e11c04696b-12ea-48c0-a853-20e0f77a6f402011-09-06WarningsExact identifier
spl id: 6e942baa-cce1-43cd-ab4a-dc24d39ac9e1
spl set id: 1c04696b-12ea-48c0-a853-20e0f77a6f40

Reported adverse events (FAERS/openFDA)#

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