Label: ORCHID CACTUS FLOWER AND MANGO- triclosan liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 August 13, 2013

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.3%

    PURPOSE

    ANTIBACTERIAL

  • USES

    FOR HAND WASHING TO DECREASE BACTERIA ON THE SKIN.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER.

    STOP USING THIS PRODUCT AND ASK DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    APPLY TO WET HANDS, LATHER AND RINSE THOROUGHLY.

  • QUESTIONS/COMMENTS?

    1-866-695-3030

  • INACTIVE INGREDIENTS:

    WATER (AQUA), SODIUM LAURETH SULFATE, ACRYLATES COPOLYMER, COCAMIDOPROPYL BETAINE, FRAGRANCE (PARFUM), SODIUM CHLORIDE, CITRIC ACID, POLYETHYLENE, SODIUM HYDROXIDE, PEG-7 GYCERYL COCOATE, PROPYLENE GLYCOL, TETRASODIUM EDTA, MANNITOL, CELLUOSE, HYDROXYPROPYL METHYLCELLULOSE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SODIUM STYRENE/PEG-10 MALEATE/NONOXYNOL-10 MALEATE/ACRYLATES COPOLYMER, AMMONIUM NONOXYNOL-4 SULFATE, ALOE BARBADENSIS LEAF JUICE POWDER, HELIANTHUS ANNUUS (SUNFLOWER) EXTRACT, CEREUS GRANDIFLORUS (CACTUS) FLOWER EXTRACT, MANGIFERA INDICA (MANGO) FRUIT EXTRACT, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), YELLOW 5 (CI 19140), RED 4 (CI 14700), RED 33 (CI 17200). 

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    ORCHID  CACTUS FLOWER AND MANGO
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-091
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    MANNITOL (UNII: 3OWL53L36A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    SELENICEREUS GRANDIFLORUS FLOWER (UNII: II877K4UNR)  
    MANGO (UNII: I629I3NR86)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-091-08236 mL in 1 BOTTLE, PLASTIC08/12/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/12/2013
    Labeler - H.E.B. (007924756)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(37808-091)
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