CASTIVA COOLING- menthol and methyl salicylate cream

Castiva Cooling by

Drug Labeling and Warnings

Castiva Cooling by is a Otc medication manufactured, distributed, or labeled by Humco Holding Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Castiva Cooling

Drug Facts

Active Ingredient

Menthol 5%

Purpose

Topical Analgesic

Active Ingredient

Methyl Salicylate 14%

Purpose

Topical Analgesic

Use

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

Warnings

For external use only. 

Allergy alert. If prone to allergic reaction from aspirin or salicylate, consult a doctor before use.

Do not use

otherwise than as directed, on damaged skin, on open wounds, with a heating pad.

Stop and ask a doctor if

condition worsens, symptoms persist for more than 7 days, or clear up and occur again within a few days.

When using this product

avoid contact with eyes. Do not bandage tightly.

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children 

to prevent accidental poisoning. In case of accidental ingestion, seek professional assistance, or contact a Poison Control Center immediately.

Directions

• Adults and children 12 yrs. of age and older. Apply to the affected area no more than 3 to 4 times daily.
  
• Children under 12 years of age: Consult a doctor.

Other Information

• Store at room temperature.

Inactive Ingredients

Castor oil, diazolidinyl urea, glyceryl monostearate, isopropyl palmitate, lecithin, methylparaben, PEG-100 stearate, poloxamer 407, polyglyceryl 1, 3- disteareate, potato starch modified, propylene glycol, propylparaben, purified water, SD Alcohol 40-B.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CASTIVA COOLING 
menthol and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-0129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	140 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-100 STEARATE (UNII: YD01N1999R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
STARCH, POTATO (UNII: 8I089SAH3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0395-0129-94	1 in 1 CARTON	12/01/2006
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/01/2006

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	manufacture(0395-0129) , label(0395-0129) , analysis(0395-0129)