CAREALL MUSLE AND JOINT- menthol gel

CAREALL Musle and Joint by

Drug Labeling and Warnings

CAREALL Musle and Joint by is a Otc medication manufactured, distributed, or labeled by New World Imports, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 2.5%

PURPOSE

Topical Analegesic

KEEP OUT OF REACH OF CHILDREN

Keep out of Reach of Children.  If swallowed, get medical help of contact a Poison Control Center immediately.

INDICATIONS & USAGE

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains, and bruises

WARNINGS

For External Use Only.

Do not use:

On wounds or damaged skin

With a heating pad

On children 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 eith eyes or mucous membranes

Do not bandage tightly

Stop use and ask a Doctor if:

Contiditon worsens or symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

Excessive skin irritation occurs

DOSAGE & ADMINISTRATION

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

Children under 12 years of age: ask a doctor

INACTIVE INGREDIENT

Camphor, Carbomer 980, Isopropyl alcohol, Methylparaben, Polysorbate 60, Potassium Sorbate, Trolamine, Purified water

QUESTIONS

You may report serious side effects / Distributed by: NWI, Inc., 160 Athens Way, Nashville,TN 37228.  (615)329-1906

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL MUSLE AND JOINT 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (Inbetween clear and white in color)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-014-03	85 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/01/2012

Labeler - New World Imports, Inc (075372276)