ESIKA WINNER BLACK ANTIPERSPIRANT ROLL-ON DEODORANT FM- aluminum sesquichlorohydrate emulsion

ESIKA WINNER BLACK ANTIPERSPIRANT ROLL-ON DEODORANT FM by

Drug Labeling and Warnings

ESIKA WINNER BLACK ANTIPERSPIRANT ROLL-ON DEODORANT 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 13.60 %

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 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, hydroxyacetophenone, tetrasodium edta, bisabolol.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

WINNER
BLACK

ANTIPERSPIRANT
ROLL-ON DEODORANT FM
does not contain alcohol

ésika

50 ml e (1.7 fl.oz.)

INGREDIENTS AND APPEARANCE

ESIKA WINNER BLACK ANTIPERSPIRANT ROLL-ON DEODORANT FM 
aluminum sesquichlorohydrate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-726
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-726-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part350	12/23/2015

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-726)