RELIEVE AND RELAX PAIN RELIEVING- camphor (synthetic), menthol gel 
MAC Innovations, LLC

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Relieve and Relax Pain Relieving

DRUG FACTS

Active Ingredients

Camphor 4.0% w/w

Menthol 10.0% w/w

Purpose

Topical Analgesic

Uses:

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

Warnings:

• For external use only.

• Flammable, Keep away from fire or flame.

• Avoid getting 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

• on wounds or damaged skin.

• Do not bandage tightly. • Caution: Discontinue use if excessive irritation of the skin develops.

Keep out of reach of children.

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

Directions:

SHAKE WELL BEFORE USE Adults and children 12 years of age and older: Using the roll-on applicator, massage a liberal amount of gel directly on the affected area not more than 3-4 times daily. Children under 12 years of age: Ask a doctor.

Other Information:

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

Inactive Ingredients:

Acrylates/Beheneth- 25 Methacrylate Copolymer,Caprylyl Glycol, Chondroitin Sulfate, Ethanol SDA 40B, Eucalyptus Oil, Glucosamine Sulfate, Glycerin, Magnesium Chloride, Peppermint Oil, Phenoxyethanol, Propylene Glycol, Triethanolamine, Water

Questions or Comments?

Call Toll Free: 954-747-3300 Monday through Friday 8:30 AM to 5:00 PM EST. Visit us: www.RelieveAndRelax.com email us: info@RelieveAndRelax.com Or Write us: MAC Innovations, LLC Attn: Quality Assurance Dept. 2301 SW 145th Ave. Miramar, FL USA 33027






Package Labeling:

Label

RELIEVE AND RELAX PAIN RELIEVING 
camphor (synthetic), menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81790-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)40 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
GLYCERIN (UNII: PDC6A3C0OX)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81790-001-0088.7 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product06/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/01/2021
Labeler - MAC Innovations, LLC (079554472)

Revised: 10/2023
Document Id: 081d8baa-7eda-5008-e063-6294a90ad5d4
Set id: c0528c36-d322-8110-e053-2995a90add6c
Version: 3
Effective Time: 20231019
 
MAC Innovations, LLC