Label: LBEL DRY EFFECT 48 ROLL-ON- aluminum sesquichlorohydrate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-425-01 - Packager: Ventura Corporation Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 18, 2012
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
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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
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label
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INGREDIENTS AND APPEARANCE
LBEL DRY EFFECT 48 ROLL-ON
aluminum sesquichlorohydrate liquidProduct 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