Castiva Cooling

Manufacturer: Humco Holding Group, Inc.
Effective date: 2020-06-19
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 23:24:56

Label at a glance#

ProductCastiva Cooling

Active ingredientMENTHOL, METHYL SALICYLATE

Label structure11 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Castiva Cooling

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 14%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

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

Do not use

OTC - DO NOT USE SECTION

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

Stop and ask a doctor if

OTC - STOP USE SECTION

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

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. Do not bandage tightly.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

Store at room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CoolingCtn.jpgCoolingTube.jpgcooling

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0395-0129-94	2022-07-29	C162847	48780-1	e4f33bdf-a2f0-d8a0-e053-dadaa90a6e4e	Castiva Cooling

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0395-0129-94	GM - Gram	0395-0129	f6955f46-a451-4b48-92ce-5641a8d28840	1	2017-06-15

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

Castiva Cooling
Menthol and Methyl Salicylate
CASTOR OIL
DIAZOLIDINYL UREA
GLYCERYL MONOSTEARATE
ISOPROPYL PALMITATE
LECITHIN, SOYBEAN
METHYLPARABEN
PEG-100 STEARATE
POLOXAMER 407
POLYGLYCERYL-3 DISTEARATE
STARCH, POTATO
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
ALCOHOL
MENTHOL
METHYL SALICYLATE
SALICYLIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0395-0129	0395-0129-94

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CASTOR OIL	D5340Y2I9G	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PEG-100 STEARATE	YD01N1999R	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
POLYGLYCERYL-3 DISTEARATE	ZI1LK470XV	IACT
STARCH, POTATO	8I089SAH3T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
MENTHOL	L7T10EIP3A	ACTIB
METHYL SALICYLATE	LAV5U5022Y	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a87209ef-91a0-211f-e053-2a95a90a602d			1935c70c-15aa-4708-b1fd-f644fa898a19	2020-06-19	Warnings	Exact identifier spl id: a87209ef-91a0-211f-e053-2a95a90a602d spl set id: 1935c70c-15aa-4708-b1fd-f644fa898a19

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.