CYZONE BODY MANIC- aluminum sesquichlorohydrate lotion

CYZONE by

Drug Labeling and Warnings

CYZONE 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 20%

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, STEARETH-21, PPG-15 STEARYL ETHER, CYCLOMETHICONE, GLYCERIN, BUTYLENE GLYCOL, LARREA DIVARICATA EXTRACT, DICAPRYLYL CARBONATE, TRICLOSAN,BENZALKONIUM CHLORIDE, METHYLPARABEN, BISABOLOL, BHT, LECITHIN, TETRASODIUM EDTA

Questions?

Puerto Rico: 622-3235 (San José)

SPL UNCLASSIFIED SECTION

Puerto Rico: Distribuited by Ventura Corporation Ltd., San Juan, Puerto Rico 00924. Made in Colombia.

PRINCIPAL DISPLAY PANEL - 50 ml Container Label

Body
manic

cy°zone

50 ml e
(1.6 fl.oz.)

INGREDIENTS AND APPEARANCE

CYZONE   BODY MANIC
aluminum sesquichlorohydrate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Aluminum Sesquichlorohydrate (UNII: UCN889409V) (Aluminum Sesquichlorohydrate - UNII:UCN889409V)	Aluminum Sesquichlorohydrate	0.2 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
CYCLOMETHICONE (UNII: NMQ347994Z)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
TRICLOSAN (UNII: 4NM5039Y5X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
METHYLPARABEN (UNII: A2I8C7HI9T)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-122-01	50 mL in 1 BOTTLE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part350	11/14/2011

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-122)