ESIKA ALTHEUS ANTIPERSPIRANT ROLL-ON DEODORANT- aluminum sesquichlorohydrate emulsion
Ventura Corporation LTD

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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ÉSIKA ALTHEUS ANTIPERSPIRANT ROLL-ON DEODORANT

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, CYCLOPENTASILOXANE, STEARETH-21, FRAGRANCE, CYCLOHEXASILOXANE, DICAPRYLYL CARBONATE, TRICLOSAN, METHYLPARABEN, TETRASODIUM EDTA, BENZALKONIUM CHLORIDE, BISABOLOL, COUMARIN, ALPHA-ISOMETHYL IONONE, d-LIMONENE, BUTYLPHENYL METHYLPROPIONAL, LINALOOL.

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

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

ALTHEUS

ANTIPERSPIRANT
ROLL-ON DEODORANT

ésika

50 ml e (1.6 fl.oz.)

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

ESIKA ALTHEUS ANTIPERSPIRANT ROLL-ON DEODORANT
aluminum sesquichlorohydrate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-845
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
STEARETH-2 (UNII: V56DFE46J5)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
STEARETH-21 (UNII: 53J3F32P58)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
TRICLOSAN (UNII: 4NM5039Y5X)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE SODIUM (UNII: MP1J8420LU)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
LEVOMENOL (UNII: 24WE03BX2T)
COUMARIN (UNII: A4VZ22K1WT)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-845-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/08/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part350	12/08/2016

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-845)