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%
Lansinoh Baby
FDA Label NDC 53997-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lansinoh Laboratories, Inc. for the product Lansinoh Baby (NDC 53997-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, inactive ingredient, purpose, warnings, keep out of reach of children, directions, other information, questions or comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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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