Label: LANSINOH BABY- dimethicone ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 53997-100-01 - Packager: Lansinoh Laboratories, Inc.
- 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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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
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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
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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
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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
- QUESTIONS OR COMMENTS
- INDICATIONS AND USES
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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)
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INGREDIENTS AND APPEARANCE
LANSINOH BABY
dimethicone ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53997-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 4.25 g in 85 g LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN 13.17 g in 85 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4.675 g in 85 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:53997-100-01 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 01/01/2011 Labeler - Lansinoh Laboratories, Inc. (181696907) Registrant - Lansinoh Laboratories, Inc. (181696907) Establishment Name Address ID/FEI Business Operations Power Line Packaging, Inc 181099342 manufacture(53997-100)