Label: LANSINOH BABY- dimethicone ointment

  • 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 December 15, 2011

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  • ACTIVE INGREDIENTS

    DRUG FACTS DIMETHICONE 5.0%  USP MODIFIED LANOLIN 15.5 %   ZINC OXIDE 5.5 %

    DATOS DEL MEDICAMENTO   DIMETICONA 5.0%  LANOLINA MODIFICADA 15.5%, CALIDAD USP   OXIDO DE ZINC 5.5%

  • INACTIVE INGREDIENT

    ALLANTOIN, BEESWAX, BISABOLO, CAPRYLIC/CAPRIC TRIGLYCERIDE, CHAMOMILLA RECUTITA (MATRICARIA)FLOWER EXTRACT, GLYCERIL BEHENATE/EICOSADIOATE, JOJOBA ESTERS, PETROLATUM, POLYDECENE, POLYETHYLENE, STEARYL GLYCYRRHETINATE, ZEA MAYS (CORN) STARCH

    ALANTOINA, CERA DE ABEJAS, BISBOLOL, TRIGLICERIDO CAPRIILICO/CAPRICO, BEHENATO/EICOSADIOATO DE GLICERILO, JOJOBA ESTERES, EXTRACTO DE FLOR DE CHAMOMILLA RECUTITA (MATRICARIA), PETROLATO, POLIDECENO, POLIETILENO, GLICIRRETINATO DE ESTEARILO, ALMIDON DE ZEA MAYS (MAIZ)

  • PURPOSE

    SKIN PROTECTANT

    PROTECTOR DE LA PIEL

  • WARNINGS

    FOR EXTERNAL USE ONLY  WHEN USING THIS PRODUCT AVOID CONTACT WITH THE EYES  STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE WITH IN 7 DAYS.

    PARA USO EXTERNO SOLAMENTE  CUANDO USE ESTE PRODUCTO  EVITE EL CONTACTO CON LOS OJOS  DEJE DE USARLO Y CONSULTE AL MEDICO SI   EL PROBLEMA SE AGRAVA O NO MEJORA EN 7 DIAS 

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.  IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

     MANTENGA FUERA DEL ALCANCE DE LOS NINOS  SI SE INGIERE, OBTENGA ATENCION MEDICA A LLAME AL INSTITUTO DE TOXICOLOGIA DE IMMEDIATO.

  • DIRECTIONS

    CHANGE WET AND SOILED DIAPERS PROMPTLY  CLEANSE THE DIAPER AREA   ALLOW TO DRY   APPLY OINTMENT LIBERALLY AS OFTEN AS NECESSARY, WITH EACH DIAPER CHANGE, ESPECIALLY AT BEDTIME OR ANY TIME WHEN EXPOSURE TO WET DIAPERS MAY BE PROLONGED

    CAMBIE SIN  DEMORS LOS PANALES MOJADOS O SUCIOS   LIMPIE LA ZONA DEL PANAL  DEJE SECAR  APLIQUE ESTE UNGENTO ABUNDANTEMENTE Y TAN A MENUDO COMO SEA NECESARIO CUANDO CAMBIE EL PANAL, ESPECIALMENTE A LA HORA DE IR A DORMIR O EN CUALQUIER SITUACION EN QUE EL CONTACTO CON EL PANAL MOJADO PUDIERA SER PROLONGADO

  • OTHER INFORMATION

    STORE BETWEEN 20 DEGREES TO 25 DEGREES C (68 DEGREES TO 77 DEGREES F)

    GUARDE ENTRE LOS 20C Y 25 C (68 F A 77 F)

  • QUESTIONS OR COMMENTS

    CALL 1-800-292-4794, WEEKDAYS.

    LLAME AL 1-800-292-4794 DE LUNES A VIERNES.

  • INDICATIONS AND USES

    TREATS DIAPER RASH   PROTECTS SKIN  PROMOTES HEALING

    TRATA LA IRRITACION POR EL PANAL  PROTEGE LA PIEL  AYUDA A SANAR

  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL

    LANSINOH BABY  LANSINOH 3-IN- 1 DIAPER RASH OINTMENT IS A UNIQUE BLEND OF THREE SPECIAL INGREDIENTS INCLUDING LANSINOH HPA LANOLIN - THE WORLD'S PUREST LANOLIN - TO HELP HEAL AND SOOTHE BABY'S BOTTOM AND HELP PREVENT IRRITATION FROM COMING BACK.

    LANSINOH BABY  LANSINOH 3-IN- 1 DIAPER RASH OINTMENT ES UNA COMBINACION EXCLUSIVA DE TRES INGREDIENTES ESPECIALES, ENTRE ELLOS LANSINOH HPA - LA LANOLINA MAS PURA DEL MUNDO - PARA CONTRIBUIR A SANAR Y SUAVIZAR EL PREVENIR QUE SE REPITA LA IRRITACION.

    MANUFACTURED FOR: LANSINOH LABORATORIES, INC. ALEXANDRIA, VA 22314  800-292-4794  LANSINOH.COM LANSINOH R AND HPA R ARE REGISTERED TRADEMARKS OF LANSINOH LABORATORIES, INC.  C 2010 LANSINOH LABORATORIES, INC. ALL RIGHTS RESERVED  MADE IN USA

    LANSINOH BABY 3-IN-1 DIAPER RASH OINTMENT TRATA LA IRRITACION POR EL PANAL  PROTEG LA PIEL  AYUDA A SANAR  HIPOALERGENICO, SIN FRAGANCIA, SIN PARABENO

    LANSINOH BABY 3-IN-1 DIAPER RASH OINTMENT  TREATS DIAPER RASH  PROTECTS SKIN  PROMOTES HEALING  HYPOALLERGENIC  FRAGRANCE FREE  PARABEN FREE

    IPARENTING MEDIA WINNER AWARD

    NET WT 3 OZ (85G)

    LANSINOH LABEL



  • INGREDIENTS AND APPEARANCE
    LANSINOH BABY 
    dimethicone ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53997-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE4.25 g  in 85 g
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN13.17 g  in 85 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.675 g  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GLYCERYL BEHENATE (UNII: R8WTH25YS2)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53997-100-0185 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2011
    Labeler - Lansinoh Laboratories, Inc. (181696907)
    Registrant - Lansinoh Laboratories, Inc. (181696907)
    Establishment
    NameAddressID/FEIBusiness Operations
    Power Line Packaging, Inc181099342manufacture(53997-100)