RELIEF PAIN RELIEVING CREAM- menthol cream 
Corganics, LP

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.

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DRUG FACTS

ACTIVE INGREDIENT

Menthol 2.5%

PURPOSE

Counterirritant

USAGE

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

WARNINGS

For external use only. If condition worsens, or if symptons persist for more than 7 days or clear up and occur again in 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, Caprylic/Capric Triglycerides, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Citrus Aurantium Dulcis (Sweet Orange) Oil, Cymbopogon Martini (Palmarosa) Oil, Deionized Water, Diazolidinyl Urea, Eucalyptus Globulus Leaf Oil, Glycerine, Iodopropynyl Butylcarbamate, L-Arginine, Lavandula Angustifolia (Lavender) Oil, Lecithin, Mentha Piperita (Peppermint Oil), Tocopherol, Methylsulfonylmethane, Tocopheryl Acetate, Triethanolamine

CONTAINER LABEL

RELIEF PAIN RELIEVING CREAM 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58559-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
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)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58559-001-015 g in 1 BLISTER PACK05/22/2004
2NDC:58559-001-0282 g in 1 BOTTLE, WITH APPLICATOR05/22/2004
3NDC:58559-001-03115 g in 1 TUBE05/22/2004
4NDC:58559-001-04450 g in 1 BOTTLE, PUMP05/22/2004
5NDC:58559-001-053600 g in 1 BOTTLE, PUMP05/22/2004
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/22/2004
Labeler - Corganics, LP (028162522)
Establishment
NameAddressID/FEIBusiness Operations
Naturich Cosmetique Labs124281663manufacture(58559-001)

Revised: 11/2014
Document Id: 1f9feebc-001c-43cc-84ee-3587dc35c749
Set id: 85814fff-35f8-447f-b669-87eaf55e9859
Version: 1
Effective Time: 20141110
 
Corganics, LP