CASTIVA WARMING- capsaicin cream

Castiva Warming by

Drug Labeling and Warnings

Castiva Warming 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 Warming

Drug Facts

Active Ingredient

Capsaicin 0.035%

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

Keep out of reach of children. 

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

Directions

• 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

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

Inactive Ingredients

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CASTIVA WARMING 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-0130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.35 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-100 STEARATE (UNII: YD01N1999R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0395-0130-94	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	analysis(0395-0130) , manufacture(0395-0130) , label(0395-0130)