CAREALL MUSLE AND JOINT- menthol gel 
New World Imports, Inc

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.

----------

Drug Facts

Menthol 2.5%

Topical Analegesic

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

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

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:

Condition worsens or symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

Excessive skin irritation occurs

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

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

MJG3 Carton Artwork

CAREALL MUSLE AND JOINT 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (Inbetween clear and white in color) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-014-0385 g in 1 TUBE; Type 0: Not a Combination Product06/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2012
Labeler - New World Imports, Inc (075372276)

Revised: 7/2021
Document Id: c83b0f62-dc0d-4fbf-a2b3-b87d4b5b86e7
Set id: 013beea4-b2c2-4e84-b4cb-3125ac48e8c0
Version: 7
Effective Time: 20210701
 
New World Imports, Inc