CASTIVA WARMING- capsaicin 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 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.

Castiva Label Castiva Carton

CASTIVA WARMING
capsaicin cream

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 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	analysis(0395-0130) , manufacture(0395-0130) , label(0395-0130)

Revised: 12/2021

Document Id: d3d209ba-434c-1f9d-e053-2a95a90aaa7f

Set id: c2d68f95-5a57-4d7f-a7f7-8fc4dc42e9eb

Version: 6

Effective Time: 20211223

Humco Holding Group, Inc.