RELIEVE AND RELAX PAIN RELIEVING (camphor- synthetic, menthol gel

Relieve and Relax Pain Relieving by

Drug Labeling and Warnings

Relieve and Relax Pain Relieving by is a Otc medication manufactured, distributed, or labeled by MAC Innovations, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

RELIEVE AND RELAX PAIN RELIEVING 
camphor (synthetic), menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81790-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	40 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81790-001-00	88.7 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	06/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/01/2021

Labeler - MAC Innovations, LLC (079554472)