FDA Label for Lansinoh Baby

The following document was submitted to the FDA by the labeler of this product Lansinoh Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 - Power Line Lansinoh Label

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