Label: ORCHID BY H E B WHITE LAVENDER AND MINT- 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 April 25, 2014

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.3%

    PURPOSE

    ANTIBACTERIAL

  • USES

    TO HELP REDUCE 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, GLYCOL DISTEARATE, MYRISTYL ALCOHOL, GLYCERIN, AMMONIUM CHLORIDE, GLYCERETH-26, COCO-GLUCOSIDE, GLYCERYL OLEATE, LAURYL LACTYL LAURATE, GLYCERY STEARATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER/LEAF/STEM EXTRACT, MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT, TOCOPHERYL ACETATE, BENZOPHENONE-4, DISODIUM EDTA, SODIUM HYDROXIDE, CITRIC ACID, BENZYL ALCOHOL, FRAGRANCE (PARFUM), MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, CAPRYLIC/CAPRIC TRIGLYCERIDE, IRON OXIDES (CI 77491), EXT. VIOLE 2 (CI 60730), RED 33 (CI 17200), MICA (CI 77019), TITANIUM DIOXIDE (CI 77891), METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    ORCHID BY H E B  WHITE LAVENDER AND MINT
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-097
    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)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    MANNITOL (UNII: 3OWL53L36A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-097-08236 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/24/2014
    Labeler - H E B (007924756)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(37808-097)
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