MUSCLE AND JOINT PAIN RELIEF GEL- menthol, eucalyptus globulus leaf oil gel

Muscle and Joint Pain Relief Gel by

Drug Labeling and Warnings

Muscle and Joint Pain Relief Gel by is a Otc medication manufactured, distributed, or labeled by Dimensional Merchandising Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Menthol 5.0%

Eucalyptus Globulus Leaf Oil 3.25%

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.

Do Not Use: On wounds or damaged skin, with a heating pad, or on a child under 12 years of age with arthritis-like conditions.

Ask a Doctor Before Use If You Have: Redness over the affected area.

When Using This Product: Avoid contact with eyes or mucous membranes; do not bandage tightly.

Stop Use and Ask Doctor If: Condition worsens or symptoms persist for more than 7 days, if symptoms clear up and occur again within a few days, or if redness is present or excessive skin irritation develops.

CAUTION: Keep away from eyes. Wash hands and fingers thoroughly.

Keep Out of Reach of Children:

 In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

Directions:

Use only as directed. After use, wipe off applicator head and replace protective cap. Clean outside with damp cloth or paper towel. Do not rinse under or immerse in water.

Adults and children 12 years of Age and older: apply to affected area not more than 3 to 4 times daily.

Children Under 12 years of Age: consult a doctor.

STORAGE AND HANDLING

Other Information: Store between 20 and 25 °C (68 and 77 °F)

Other Ingredients:

Water, Alcohol Denatured, Glycerin, Piper Methysticum Leaf/Root/Stem Extract, Calendula Officinalis Flower Extract, Arnica Montana Flower Extract, Carbomer, Butylene Glycol, Propylene Glycol, Polysorbate 20, Chlorphenesin, Sodium Hydroxide, Sodium Benzoate, Potassium Sorbate.

SPL UNCLASSIFIED SECTION

NatureWell™ CLINICAL

WITH KAVA EXTRACT

MUSCLE STRAINS

JOINT PAIN

STRAINS AND CRAMPS

TEMPORARY PAIN RELIEF  SOOTHES ACHES & PAINS  QUICK VANISHING ODOR

FAST-ACTING  NON-GREASY  QUICK-DRY FORMULA 

HANDS FREE ROLLER BALL APPLICATION

MESS-FREE MASSAGING APPLICATOR

No Parabens  Dye-Free

Not Tested on Animals

Formula Made in the USA

Soothe aching muscles and joints with NatureWell™ Clinical 

In an easy to use roll-on applicator, this product glides on for targeted, cooling relief. Formulated with 5% Menthol and 3.25% Eucalyptus Oil to reduce aches and pain. This no-mess, fast acting gel temporarily alleviates any aches or pains. Great for muscle strains, sprains and cramps.

BENEFITS

• FAST RELIEF 
• SOOTHES ACHES AND PAINS
• QUICK VANISHING ODUR
• NO MESS APPLICATOR

KEY INGREDIENTS

• 5% Menthol - Helps relieve joint and muscle pain
• 3.25% Eucalyptus Oil - Helps relieve sore, stiff muscles
• Kava Extract - Helps provide additional cooling benefits
• Arnica & Calendula Extracts - Helps calm and comfort

DISTRIBUTED BY:

NATUREWELL™

PHOENIX, AZ 85016

Packaging

INGREDIENTS AND APPEARANCE

MUSCLE AND JOINT PAIN RELIEF GEL 
menthol, eucalyptus globulus leaf oil gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61383-701
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	5 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	3.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
PIPER METHYSTICUM ROOT (UNII: BOW48C81XP)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61383-701-01	2 in 1 BLISTER PACK	11/16/2016
1	NDC: 61383-701-96	96 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/16/2016

Labeler - Dimensional Merchandising Inc. (076693183)

Establishment
Name	Address	ID/FEI	Business Operations
Dimensional Merchandising Inc.		076693183	manufacture(61383-701)