FDA.reportPublic FDA data

Relieve and Relax Pain Relieving

Manufacturer
MAC Innovations, LLC
Effective date
2026-08-08
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-08-21 02:02:09

Label at a glance#

ProductRelieve and Relax Pain Relieving
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure8 sections

Indications and uses

Temporarily relieves the minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage and administration

Shake Well Before Use 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 doctor. Adults and Children 2 years of age and older: Apply to affected area not more then 3 to 4 times daily. Children under 2 years of age: Consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 4.0% w/w
Menthol 10.0% w/w

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

  • Temporarily relieves the minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

WARNINGS SECTION

• For external use only.
• Flammable,Keep away from fire or flame.
• Avoidgetting into eyes or on mucous membranes.
• If conditions worsens,or if symptoms persist for more than 7 days or clear up and occur within a few days, discontinue use of this product and consult a doctor.

DO NOT use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin.
  • DO NOTbandage tightly.
  • CAUTION:Discontinue use if excessive irritation of the skin develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Use only as directed. • Do not use • If swallowed, get medical help or contact a poison control center right away.

if pregnant or breastfeeding.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake Well Before Use
  • 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 doctor.

Shake Well Before Use

RECENT MAJOR CHANGES SECTION

  • Adults and Children 2 years of age and older: Apply to affected area not more then 3 to 4 times daily.
  • Children under 2 years of age: Consult a doctor.

Other Information

SPL UNCLASSIFIED SECTION

  • Store between 10 and 30º C (50-86 ºF) 
  • Avoid freezing and excessive heat above 32º C (90 ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat., Acrylates/Beheneth-25 Methacrylate Copolymer, Caprylyl Glycol, Chondroitin Sulfate, Eucalyptus Globulus Leaf Oil, Glucosamine HCl, Glycerin, Magnesium Chloride, Mentha Piperita (Peppermint) Oil, Phenoxyethanol, Potassium Chloride, Propylene Glycol, Sorbic Acid, Triethanolamine, Water

Questions:

OTC - QUESTIONS SECTION

1-877-848-2337 RelieveAndRelax.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130859856005000GTIN-13: 0859856005000
EAN-13: 0859856005000
GTIN-12: 859856005000
UPC-A: 859856005000
GTIN storage (14 digits): 00859856005000		Label0.jpg
QR code linkQR Codeqrcodes.pro/dTWo2sLabel0.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81790-00181790-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
ALCOHOL3K9958V90MIACT
CAPRYLYL GLYCOL00YIU5438UIACT
EUCALYPTUS OIL2R04ONI662IACT
GLUCOSAMINE HYDROCHLORIDE750W5330FYIACT
GLYCERINPDC6A3C0OXIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
PEPPERMINT OILAV092KU4JHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM CHLORIDE660YQ98I10IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBIC ACIDX045WJ989BIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-12-29full-release2026-06-01 01:29:27
72025-11-12monthly-update2026-06-03 17:39:51
52025-09-30full-release2026-06-01 01:15:21

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
Relieve and Relax Pain RelievingCAMPHOR (SYNTHETIC), MENTHOLMAC Innovations, LLCc0528c36-d322-8110-e053-2995a90add6c2026-08-08WarningsExact identifier
ndc (package): 81790-001-00
ndc (product): 81790-001
ndc11 (package): 81790000100
spl id: 588b6242-a45b-7886-e063-6294a90a8858
spl set id: c0528c36-d322-8110-e053-2995a90add6c

Reported adverse events (FAERS/openFDA)#

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