CASTIVA COOLING- menthol and methyl salicylate cream 
Humco Holding Group, Inc.

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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Castiva Cooling

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

Other Information

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.

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CASTIVA COOLING 
menthol and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-0129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE140 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0395-0129-941 in 1 CARTON12/01/2006
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/01/2006
Labeler - Humco Holding Group, Inc. (825672884)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIBusiness Operations
Humco Holding Group, Inc.825672884manufacture(0395-0129) , label(0395-0129) , analysis(0395-0129)

Revised: 6/2020
Document Id: a87209ef-91a0-211f-e053-2a95a90a602d
Set id: 1935c70c-15aa-4708-b1fd-f644fa898a19
Version: 4
Effective Time: 20200619
 
Humco Holding Group, Inc.