FDA.reportPublic FDA data

Castiva Warming

Manufacturer
Humco Holding Group, Inc.
Effective date
2021-12-23
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:21:18

Label at a glance#

ProductCastiva Warming
Active ingredientCAPSAICIN
Label structure9 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. To achieve optimum pain relief, apply daily as directed. Transient burning may occur upon application, but generally disappears in several days. WASH HANDS THROUGHLY AFTER USE TO AVOID SPREADING LOTION TO THE EYES. If applying lotions to hands, wait 30 minutes before washing hands. . Children under 12 years of...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Castiva Warming

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.035%

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. Do not use on damaged skin, on 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. Avoid inhaling dried residue from application site which may cause sneezing, nasal irritation or tearing.

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

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. To achieve optimum pain relief, apply daily as directed. Transient burning may occur upon application, but generally disappears in several days. WASH HANDS THROUGHLY AFTER USE TO AVOID SPREADING LOTION TO THE EYES. If applying lotions to hands, wait 30 minutes before washing hands. .
  • Children under 12 years of age: Consult a doctor before use.

Other Information

OTHER SAFETY INFORMATION

  • Store at room temperature. Apply carefully. May stain clothes.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Castiva LabelCastiva LabelCastiva CartonCastiva CartonCastivaW.jpgCastivaW.jpgWarmingTube.jpgWarmingTube.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0395-0130-942022-07-29C16284748780-1e4f33bdf-a980-d8a0-e053-dadaa90a6e4eCastiva Warming

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-0130-94GM - Gram0395-013080ca98d5-92fc-4b8b-bf8e-007d4fb5f4e112017-06-15

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0395-01300395-0130-94

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CASTOR OILD5340Y2I9GIACT
CETYL ALCOHOL936JST6JCNIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
METHYLPARABENA2I8C7HI9TIACT
PEG-100 STEARATEYD01N1999RIACT
POLOXAMER 407TUF2IVW3M2IACT
POLYGLYCERYL-3 DISTEARATEZI1LK470XVIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
CAPSAICINS07O44R1ZMACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d3d209ba-434c-1f9d-e053-2a95a90aaa7fc2d68f95-5a57-4d7f-a7f7-8fc4dc42e9eb2021-12-23WarningsExact identifier
spl id: d3d209ba-434c-1f9d-e053-2a95a90aaa7f
spl set id: c2d68f95-5a57-4d7f-a7f7-8fc4dc42e9eb

Reported adverse events (FAERS/openFDA)#

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