RELIEF PAIN RELIEVING CREAM- menthol cream

Relief Pain Relieving Cream by

Drug Labeling and Warnings

Relief Pain Relieving Cream by is a Otc medication manufactured, distributed, or labeled by Corganics, LP, Naturich Cosmetique Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RELIEF PAIN RELIEVING CREAM 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58559-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58559-002-01	5 g in 1 BLISTER PACK; Type 0: Not a Combination Product	05/22/2004
2	NDC: 58559-002-02	82 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/22/2004
3	NDC: 58559-002-03	115 g in 1 TUBE; Type 0: Not a Combination Product	05/22/2004
4	NDC: 58559-002-04	450 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/22/2004
5	NDC: 58559-002-05	3600 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/22/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/22/2004

Labeler - Corganics, LP (028162522)

Establishment
Name	Address	ID/FEI	Business Operations
Naturich Cosmetique Labs		124281663	manufacture(58559-002)