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Relief Pain Relieving Cream by Corganics, LP

Medically reviewed on Dec 21, 2017

Dosage form: cream
Ingredients: MENTHOL 3.0g in 100g
Labeler: Corganics, LP
NDC Code: 58559-002

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

ACTIVE INGREDIENT

Menthol 3%

PURPOSE

Counterirritant

USAGE

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

WARNINGS

For external use only. Avoid contact with the eyes. If condition worsens, or if symptons persist for more than 7 days or clear up and occur again after a few days, discontinue use of this product and consult a physician.

Do Not Use

  • on wounds or damaged skin
  • when bandaged tightly or with a heating pad
  • with other topical products

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

DIRECTIONS
  • Adults and children 2 years old and older: apply a small amount to affected area not more than 3 to 4 times daily.
  • Gently massage until absorbed.
  • Children under 2 years of age: consult a physician.

INACTIVE INGREDIENTS

Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Caprylic/Capric Triglycerides, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Citrus Aurantium Dulcis (Sweet Orange) Oil, Cymbopogon Martini (Palmarosa) Oil, Deionized Water, Eucalyptus Globulus Leaf Oil, Glycerine, L-Arginine Monohydrochloride, Lavandula Angustifolia (Lavender) Oil, Lecithin, Mentha Piperita (Peppermint Oil), Methylsulfonylmethane, Phenoxyethanol, Potassium Hydroxide, Tocopheryl Acetate

RELIEF PAIN RELIEVING CREAM 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58559-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL3.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE 
BENZYL ALCOHOL 
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE 
CARBOMER COPOLYMER TYPE A 
POLYOXYL 20 CETOSTEARYL ETHER 
CETOSTEARYL ALCOHOL 
CETYL ALCOHOL 
ORANGE OIL 
PALMAROSA OIL 
WATER 
EUCALYPTUS OIL 
GLYCERIN 
ARGININE 
LAVENDER OIL 
HYDROGENATED SOYBEAN LECITHIN 
DIMETHYL SULFONE 
PEPPERMINT OIL 
PHENOXYETHANOL 
POTASSIUM HYDROXIDE 
.ALPHA.-TOCOPHEROL ACETATE 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58559-002-015 g in 1 BLISTER PACK
2NDC:58559-002-0282 g in 1 BOTTLE, WITH APPLICATOR
3NDC:58559-002-03115 g in 1 TUBE
4NDC:58559-002-04450 g in 1 BOTTLE, PUMP
5NDC:58559-002-053600 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/22/2004
Labeler - Corganics, LP (028162522)
Establishment
NameAddressID/FEIOperations
Naturich Cosmetique Labs124281663manufacture(58559-002)

 
Corganics, LP

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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