RELIEVE AND RELAX PAIN RELIEVING- menthol gel
Ruggiero Innovations LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Relieve & Relax Pain Relieving Gel

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:

Bottle

RELIEVE AND RELAX PAIN RELIEVING
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72155-001
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72155-001-00	88.7 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2018

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

Labeler - Ruggiero Innovations LLC (080983107)

Revised: 12/2020

Document Id: b6355639-1439-9c48-e053-2995a90a7d35

Set id: 0f84330f-6bbe-454e-8834-9a002a922db6

Version: 2

Effective Time: 20201211

Ruggiero Innovations LLC