ESIKA  HIGHWAY ROLL-ON- aluminum sesquichlorohydrate liquid 
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 HIGHWAY Antiperspirant Roll-on Deodorant

Drug Facts

Active Ingredient

Aluminum sesquichlorohydrate 13.6 %

Purpose

Antiperspirant

Uses

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

Inactive ingredients

AQUA (WATER), STEARETH-2, PPG-15 STEARYL ETHER, STEARETH-21, PARFUM (FRAGRANCE), DICAPRYLYL CARBONATE, CYCLOPENTASILOXANE, TRICLOSAN, CYCLOHEXASILOXANE, TETRASODIUM EDTA, BENZALKONIUM CHLORIDE, BISABOLOL, MAGNESIUM NITRATE, METHYLCHLOROISOTHIAZOLINONE, MAGNESIUM CHLORIDE, METHYLISOTHIAZOLINONE.

PR: Dist. By Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 50 ml Container Label

HIGHWAY

ANTIPERSPIRANT
ROLL-ON DEODORANT
does not contain alcohol

ésika

50 ml e (1.7 fl.oz.)

Principal Display Panel - 50 ml Container Label
ESIKA   HIGHWAY ROLL-ON
aluminum sesquichlorohydrate liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-437
Route of Administration TOPICAL DEA Schedule     
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)  
TRICLOSAN (UNII: 4NM5039Y5X)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
EDETATE SODIUM (UNII: MP1J8420LU)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
LEVOMENOL (UNII: 24WE03BX2T)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-437-01 50 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part350 02/01/2013
Labeler - Ventura Corporation LTD. (602751344)
Establishment
Name Address ID/FEI Business Operations
Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-437)

Revised: 2/2013
Document Id: c8a8893b-0e0d-49c6-bdad-19f9f43fc343
Set id: cb8764f9-efc6-4f4d-8c6f-4c191ec613da
Version: 1
Effective Time: 20130201
 
Ventura Corporation LTD.