LBEL DRY EFFECT 48 ROLL-ON- aluminum sesquichlorohydrate liquid

LBEL by

Drug Labeling and Warnings

LBEL 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%

Purpose

Antiperspirant

Uses

• Reduces underarm perspiration
• All day extra effective protection

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

AQUA (WATER), STEARETH-2, STEARETH-21, PPG-15 STEARYL ETHER, COCO-CAPRYLATE, DICAPRYLYL CARBONATE, PARFUM (FRAGRANCE), TRICLOSAN, POLYVINYL ALCOHOL, METHYLPARABEN, BISABOLOL, PROPYLENE CARBONATE, BENZALKONIUM CHLORIDE, PEG-20 CASTOR OIL, BHT, ALCOHOL DENAT., PROPYLENE GLYCOL, STEARALKONIUM HECTORITE, HYDROLYZED SILK, TETRASODIUM EDTA, ZEA MAYS OIL(ZEA MAYS (CORN) OIL), ACRYLATES / C12-22 ALKYL METHACRYLATE COPOLYMER, CINNAMOMUM ZEYLANICUM BARK EXTRACT, CITRUS LIMON PEEL EXTRACT (CITRUS LIMON (LEMON) PEEL EXTRACT ), CYMBOPOGON CITRATUS EXTRACT, HYDRASTIS CANADENSIS ROOT EXTRACT (HYDRASTIS CANADENSIS (GOLDENSEAL) ROOT EXTRACT), HYDROLYZED CORN STARCH, HYDROLYZED CORN STARCH OCTENYLSUCCINATE, LAVANDULA ANGUSTIFOLIA FLOWER EXTRACT (LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT), MELALEUCA ALTERNIFOLIA LEAF (MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF), MENTHA PIPERITA LEAF EXTRACT(MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT), OLEA EUROPAEA LEAF EXTRACT (OLEA EUROPAEA (OLIVE) LEAF EXTRACT), ORIGANUM VULGARE LEAF EXTRACT, ROSMARINUS OFFICINALIS LEAF EXTRACT (ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT), THYMUS VULGARIS EXTRACT (THYMUS VULGARIS (THYME) EXTRACT), ZEA MAYS STARCH (ZEA MAYS (CORN) STARCH), CALCIUM PANTOTHENATE, INOSITOL, RETINOL, ROSA MOSCHATA SEED OIL, BIOTIN, TOCOPHERYL ACETATE

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

antiperspirant deodorant
roll on

dry effect
48

L'BEL

50 ml e (1.69 fl.oz)

INGREDIENTS AND APPEARANCE

LBEL   DRY EFFECT 48 ROLL-ON
aluminum sesquichlorohydrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-425
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)
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE SODIUM (UNII: MP1J8420LU)
CORN OIL (UNII: 8470G57WFM)
CINNAMON BARK OIL (UNII: XE54U569EC)
LEMON PEEL (UNII: 72O054U628)
GOLDENSEAL (UNII: ZW3Z11D0JV)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
OREGANO (UNII: 0E5AT8T16U)
ROSEMARY (UNII: IJ67X351P9)
THYME (UNII: CW657OBU4N)
STARCH, CORN (UNII: O8232NY3SJ)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
INOSITOL (UNII: 4L6452S749)
RETINOL (UNII: G2SH0XKK91)
ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)
BIOTIN (UNII: 6SO6U10H04)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-425-01	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	01/20/2012

Labeler - Ventura Corporation Ltd. (602751344)

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