FDA.reportPublic FDA data

Reliefor

Manufacturer
Systems Health, LLC
Effective date
2018-05-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:57:20

Label at a glance#

ProductReliefor
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: • arthritis • strains • bruises • sprains • joint discomfort

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Directly massage into achy points of the body. Wash hands after use with cool water. Product will gradually activate and warm to provide long-lasting relief. Children under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 6%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

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

• arthritis • strains • bruises • sprains • joint discomfort

Warnings:

WARNINGS SECTION

For external use only. Avoid contact with eyes. 

Do not use 

OTC - DO NOT USE SECTION

  • on wounds, damaged skin, or irritated areas
  • a heating pad in area where product is applied

When using this product:

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with eyes and mucous membranes
  • do not bandage or cover tightly
  • do not use with other topical products without first consulting a healthcare professional

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • conditions worsen, or if symptoms persist for more than 7 days
  • conditions clear up and occur again within a few days

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

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. Directly massage into achy points of the body. Wash hands after use with cool water. Product will gradually activate and warm to provide long-lasting relief.
  • Children under 2 years of age: consult a doctor.

Inactive Ingredients :

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Boswellia Serrata Extract, Carbomer, Dimethicone, Dimethyl Sulfone (MSM), Disodium EDTA, Ethylhexylglycerin, FD&C Blue #1, Hydroxypropyl Methylcellulose, Oleth-10, Phenoxyethanol, Propylene Glycol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sorbitan Oleate, Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine, Water

Other Information:

SPL UNCLASSIFIED SECTION

Store in a cool, dry place with cap closed tightly.

Questions:

OTC - QUESTIONS SECTION

1-904-834-0S4H Systems4Health.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130852002005206GTIN-13: 0852002005206
EAN-13: 0852002005206
GTIN-12: 852002005206
UPC-A: 852002005206
GTIN storage (14 digits): 00852002005206		Label.jpg

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
72331-32872331-328-00

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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
OLETH-10JD797EF70JIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALMOND OIL66YXD4DKO9IACT
SORBITAN MONOOLEATE06XEA2VD56IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB

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
074b6340-0481-ab05-e063-6294a90adedb3f90f4d8-b906-4283-a02a-d696d9f77e5d2023-10-09WarningsExact identifier
spl set id: 3f90f4d8-b906-4283-a02a-d696d9f77e5d

Reported adverse events (FAERS/openFDA)#

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