ESIKA ITS YOU ANTIPERSPIRANT ROLL-ON DEODORANT- aluminum sesquichlorohydrate emulsion

ESIKA ITS YOU ANTIPERSPIRANT ROLL-ON DEODORANT by

Drug Labeling and Warnings

ESIKA ITS YOU ANTIPERSPIRANT ROLL-ON DEODORANT by is a Otc medication manufactured, distributed, or labeled by Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

ALUMINUM SESQUICHLOROHYDRATE 13.60 %

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 disease

Stop use 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, PPG-15 STEARYL ETHER, STEARETH-2, STEARETH-21, CYCLOPENTASILOXANE, FRAGRANCE, DICAPRYLYL CARBONATE, CYCLOHEXASILOXANE, TRICLOSAN, METHYLPARABEN, TETRASODIUM EDTA, BENZALKONIUM CHLORIDE, BISABOLOL, HEXYL CINNAMAL, LINALOOL, d-LIMONENE, BUTYLPHENYL METHYLPROPIONAL, CITRONELLOL, COUMARIN, GERANIOL, CITRAL.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

IT'S
YOU

ANTIPERSPIRANT
ROLL-ON DEODORANT

ésika

50 ml e (1.6 fl.oz.)

INGREDIENTS AND APPEARANCE

ESIKA ITS YOU ANTIPERSPIRANT ROLL-ON DEODORANT 
aluminum sesquichlorohydrate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-851
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)
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
TRICLOSAN (UNII: 4NM5039Y5X)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE SODIUM (UNII: MP1J8420LU)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
LEVOMENOL (UNII: 24WE03BX2T)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
COUMARIN (UNII: A4VZ22K1WT)
GERANIOL (UNII: L837108USY)
CITRAL (UNII: T7EU0O9VPP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-851-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/09/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part350	12/09/2016

Labeler - Bel Star S.A. (Colombia) (880160197)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14141-851)