RELIEF PAIN RELIEVING CREAM- menthol cream 
Corganics, LP

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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

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

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

CONTAINER LABEL

RELIEF PAIN RELIEVING CREAM 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58559-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ORANGE OIL (UNII: AKN3KSD11B)  
PALMAROSA OIL (UNII: 0J3G3O53ST)  
WATER (UNII: 059QF0KO0R)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
ARGININE (UNII: 94ZLA3W45F)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58559-002-015 g in 1 BLISTER PACK; Type 0: Not a Combination Product05/22/2004
2NDC:58559-002-0282 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/22/2004
3NDC:58559-002-03115 g in 1 TUBE; Type 0: Not a Combination Product05/22/2004
4NDC:58559-002-04450 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/22/2004
5NDC:58559-002-053600 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/22/2004
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01705/22/2004
Labeler - Corganics, LP (028162522)
Establishment
NameAddressID/FEIBusiness Operations
JW Nutritional LLC017642837manufacture(58559-002)

Revised: 10/2023
Document Id: 3c595637-ebd2-43db-b40f-1f5ac2dbe234
Set id: b92e7078-cdaa-4c7d-a6e4-1a8e5bb1d5e1
Version: 7
Effective Time: 20231026
 
Corganics, LP