LBEL DRY EFFECT 48- aluminum chlorohydrate aerosol, spray

LBEL by

Drug Labeling and Warnings

LBEL by is a Otc medication manufactured, distributed, or labeled by Ventura International Ltd, Retycol S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Aluminum Chlorohydrate 24%

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

When using this product

• Keep away from face and mouth to avoid breathing it.
• Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 deg. F.
• Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

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

BUTANE, ISOBUTANE, PROPANE, CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE,DISTEARDIMONIUM HECTORITE, FRAGRANCE, WATER, TRICLOSAN, HELIANTHUS ANNUUS SEED OIL (HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL), POLYVINYL ALCOHOL, SERICA (SILK), CORYLUS AVELLANA SEED OIL (CORYLUS AVELLANA (HAZEL) SEED OIL), TRITICUM VULGARE GERM OIL (TRITICUM VULGARE (WHEAT) GERM OIL), CITRUS LIMON PEEL EXTRACT (CITRUS LIMON (LEMON) PEEL EXTRACT), CINNAMOMUM ZEYLANICUM BARK EXTRACT, LAVANDULA ANGUSTIFOLIA FLOWER EXTRACT (LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT), 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), HYDRASTIS CANADENSIS ROOT EXTRACT (HYDRASTIS CANADENSIS (GOLDENSEAL) ROOT EXTRACT), CYMBOPOGON CITRATUS EXTRACT, ACRYLATES / C12-22 ALKYL METHACRYLATE COPOLYMER, ZEA MAYS STARCH (ZEA MAYS (CORN) STARCH), HYDROLYZED CORN STARCH, HYDROLYZED CORN STARCH OCTENYLSUCCINATE, THYMUS VULGARIS EXTRACT (THYMUS VULGARIS (THYME) EXTRACT), MELALEUCA ALTERNIFOLIA LEAF (MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF), PRUNUS AMYGDALUS DULCIS OIL (PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL), TOCOPHERYL ACETATE, HYPERICUM PERFORATUM FLOWER EXTRACT, BORAGO OFFICINALIS EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, ASCORBYL PALMITATE

SPL UNCLASSIFIED SECTION

*DERMATOLOGICALLY TESTED * HYPOALLERGENIC

US: Dist. By Ventura International Ltd. San Francisco, CA 94111. Made in Colombia

PRINCIPAL DISPLAY PANEL - 125 ml Can Label

antiperspirant deodorant

L'BEL
dryeffect
48

125 ml e (4.2 fl.oz)

INGREDIENTS AND APPEARANCE

LBEL   DRY EFFECT 48
aluminum chlorohydrate aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-437
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M) (ALUMINUM CHLOROHYDRATE - UNII:HPN8MZW13M)	ALUMINUM CHLOROHYDRATE	0.24 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTANE (UNII: 6LV4FOR43R)
ISOBUTANE (UNII: BXR49TP611)
PROPANE (UNII: T75W9911L6)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
WATER (UNII: 059QF0KO0R)
TRICLOSAN (UNII: 4NM5039Y5X)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYVINYL ALCOHOL (UNII: 532B59J990)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG)
WHEAT GERM OIL (UNII: 14C97E680P)
LEMON PEEL (UNII: 72O054U628)
CINNAMON BARK OIL (UNII: XE54U569EC)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
OREGANO (UNII: 0E5AT8T16U)
ROSEMARY (UNII: IJ67X351P9)
GOLDENSEAL (UNII: ZW3Z11D0JV)
STARCH, CORN (UNII: O8232NY3SJ)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
THYME (UNII: CW657OBU4N)
ALMOND OIL (UNII: 66YXD4DKO9)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)
BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-437-01	125 mL in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part350	01/20/2012

Labeler - Ventura International Ltd (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Retycol S.A. (Colombia)		880131693	MANUFACTURE(14783-437)