LBEL DRY EFFECT 48 ANTIPERSPIRANT DEODORANT ROLL-ON- aluminum sesquichlorohydrate emulsion

LBEL DRY EFFECT 48 ANTIPERSPIRANT DEODORANT ROLL-ON by

Drug Labeling and Warnings

LBEL DRY EFFECT 48 ANTIPERSPIRANT DEODORANT ROLL-ON 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 18.00%

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, COCO-CAPRYLATE, DICAPRYLYL CARBONATE, FRAGRANCE, TRICLOSAN, POLYVINYL ALCOHOL, METHYLPARABEN, BISABOLOL, PROPYLENE CARBONATE, BENZALKONIUM CHLORIDE, PEG-20 CASTOR OIL, BHT, ACRYLATES/C12-22 ALKYL METHACRYLATE COPOLYMER, ALCOHOL DENAT., PROPYLENE GLYCOL, STEARALKONIUM HECTORITE, MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT, THYMUS VULGARIS (THYME) EXTRACT, HYDROLYZED SILK, TETRASODIUM EDTA, ORIGANUM VULGARE LEAF EXTRACT, ZEA MAYS (CORN) OIL, CALCIUM PANTOTHENATE, INOSITOL, RETINOL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, ROSA MOSCHATA SEED OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT, CINNAMOMUM ZEYLANICUM BARK EXTRACT, HYDRASTIS CANADENSIS (GOLDENSEAL) ROOT EXTRACT, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, CITRUS LIMON (LEMON) PEEL EXTRACT, CYMBOPOGON CITRATUS EXTRACT, HYDROLYZED CORN STARCH, HYDROLYZED CORN STARCH OCTENYLSUCCINATE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF, ZEA MAYS (CORN) STARCH, BIOTIN, TOCOPHERYL ACETATE, HEXYL CINNAMAL, BUTYLPHENYL METHYLPROPIONAL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, LINALOOL, ALPHA-ISOMETHYL IONONE, CITRONELLOL, COUMARIN.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

antiperspirant deodorant
roll on

L'BEL
dryeffect
48

50 ml e (1.7 fl.oz.)

INGREDIENTS AND APPEARANCE

LBEL DRY EFFECT 48 ANTIPERSPIRANT DEODORANT ROLL-ON 
aluminum sesquichlorohydrate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-956
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V)	ALUMINUM SESQUICHLOROHYDRATE	0.18 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
COCO-CAPRYLATE (UNII: 4828G836N6)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
TRICLOSAN (UNII: 4NM5039Y5X)
POLYVINYL ALCOHOL (UNII: 532B59J990)
METHYLPARABEN (UNII: A2I8C7HI9T)
LEVOMENOL (UNII: 24WE03BX2T)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
THYME (UNII: CW657OBU4N)
EDETATE SODIUM (UNII: MP1J8420LU)
OREGANO (UNII: 0E5AT8T16U)
CORN OIL (UNII: 8470G57WFM)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
INOSITOL (UNII: 4L6452S749)
RETINOL (UNII: G2SH0XKK91)
ROSEMARY (UNII: IJ67X351P9)
ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
CINNAMON BARK OIL (UNII: XE54U569EC)
GOLDENSEAL (UNII: ZW3Z11D0JV)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
LEMON PEEL (UNII: 72O054U628)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
STARCH, CORN (UNII: O8232NY3SJ)
BIOTIN (UNII: 6SO6U10H04)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
COUMARIN (UNII: A4VZ22K1WT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-956-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/05/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part350	07/05/2016

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-956)