RELIEVE AND RELAX PAIN RELIEVING- 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 For Life Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients (% by weight)

Camphor 4.0%

Menthol 10.0%

Purpose

Topical Analgesic (pain relief)

Uses:

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

Warnings:

For external use only.
Caution: Discontinue use if excessive irritation of the skin develops. 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.

Keep out of reach of children.

• Use only as directed.
• If swallowed, get medical help or contact a poison control center right away.
• Flammable  keep away from fire or flame.

• Do not use if pregnant or breastfeeding.

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:

Protect this product from excessive heat or direct sun. Store away from children.

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

Package Labeling:

INGREDIENTS AND APPEARANCE

RELIEVE AND RELAX PAIN RELIEVING 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72576-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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: 72576-001-00	88.7 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/01/2018

Labeler - For Life Products, LLC (050159982)