CYZONE NITRO DESODORANTE ANTITRANSPIRANTE ROLL-ON FM- aluminum sesquichlorohydrate emulsion

CYZONE NITRO DESODORANTE ANTITRANSPIRANTE ROLL-ON FM by

Drug Labeling and Warnings

CYZONE NITRO DESODORANTE ANTITRANSPIRANTE ROLL-ON FM by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Aluminum sesquichlorohydrate 13.6 %

Purpose

Antiperspirant

Uses

• Reduces underarm perspiration

Warnings

For external use only

Do not use on broken skin

Ask a doctor before use if you have Kidney desease

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

WATER, STEARETH-2, PPG-15 STEARYL ETHER, STEARETH-21, FRAGRANCE, DICAPRYLYL CARBONATE, CYCLOPENTASILOXANE, BENZYL ALCOHOL, TRICLOSAN, CYCLOHEXASILOXANE, TETRASODIUM EDTA, BISABOLOL, LINALOOL, d-LIMONENE, HEXYL CINNAMAL, BENZYL SALICYLATE, BUTYLPHENYL METHYLPROPIONAL, COUMARIN, CITRONELLOL, EUGENOL, CITRAL, ALPHA-ISOMETHYL IONONE, GERANIOL.

SPL UNCLASSIFIED SECTION

Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico
00926

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

NITRO
Desodorante Antitranspirante Roll On FM

cy°zone 50 ml e (1.7 fl.oz.)

INGREDIENTS AND APPEARANCE

CYZONE NITRO DESODORANTE ANTITRANSPIRANTE ROLL-ON FM 
aluminum sesquichlorohydrate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-963
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V)	ALUMINUM SESQUICHLOROHYDRATE	0.136 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STEARETH-2 (UNII: V56DFE46J5)
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
STEARETH-21 (UNII: 53J3F32P58)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TRICLOSAN (UNII: 4NM5039Y5X)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
EDETATE SODIUM (UNII: MP1J8420LU)
LEVOMENOL (UNII: 24WE03BX2T)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
COUMARIN (UNII: A4VZ22K1WT)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
EUGENOL (UNII: 3T8H1794QW)
CITRAL (UNII: T7EU0O9VPP)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
GERANIOL (UNII: L837108USY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-963-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/11/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part350	07/11/2016

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-963)