Label: ORCHID- 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 13, 2012

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.3%

    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, GLYCOL DISTEARATE, MYRISTYL ALCOHOL, COCAMIDOPROPYL BETAINE, GLYCERIN, AMMONIUM CHLORIDE, GLYCERETH-26, COCO-GLUCOSIDE, GLYCERYL OLEATE, LAURYL LACTYL LACTATE, 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, IRON OXIDES (CI 77491), EXT. VIOLET 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 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-297
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    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)  
    HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)  
    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:37808-297-08236 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/12/2012
    Labeler - HEB (007924756)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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