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

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.

cooling

CASTIVA COOLING
menthol and methyl salicylate cream

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/01/2006

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Humco Holding Group, Inc. (825672884)

Name	Address	ID/FEI	Business Operations
Establishment
Humco Holding Group, Inc.		825672884	manufacture(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.