CYZONE- aluminum sesquichlorohydrate liquid

CYZONE by

Drug Labeling and Warnings

CYZONE by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation (San Juan, P.R), Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Aluminum sesquichlorohydrate 17%

Purpose

Antiperspirant

Use

• Reduces underarm perspiration

Warnings

For external use only

Do not use on broken skin

Ask a doctor before use if you have kidney disease

Stop use and ask a doctor if rash or irritation occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply to underarms only

Inactive Ingredients

Aqua (water), steareth-2,ppg-15 stearyl ether, steareth-21, parfum (fragrance), dicaprylyl carbonate, cyclopentasiloxane, triclosan, cyclohexasiloxane, tetrasodium edta, benzalkonium chloride, bisabolol, magnesium nitrate, methylchloroisothiazolinone, magnesium chloride, methylisothiazolinone.

Questions?

P.R.: 622-3235 (San José).

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

NITRO

Desodorante Antitranspirante Roll On

cy°zone 50 ml e (1.6 fl.oz.)

INGREDIENTS AND APPEARANCE

CYZONE   NITRO DESODORANTE ANTITRANSPIRANTE ROLL ON
aluminum sesquichlorohydrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-362
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Aluminum Sesquichlorohydrate (UNII: UCN889409V) (Aluminum Sesquichlorohydrate - UNII:UCN889409V)	Aluminum Sesquichlorohydrate	0.17 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TRICLOSAN (UNII: 4NM5039Y5X)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
EDETATE SODIUM (UNII: MP1J8420LU)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
LEVOMENOL (UNII: 24WE03BX2T)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-362-01	50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part350	05/27/2011

Labeler - Ventura Corporation (San Juan, P.R) (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE