LANSINOH BABY

Dosage form: ointment
Ingredients: DIMETHICONE 4.25g in 85g, LANOLIN 13.175g in 85g, ZINC OXIDE 4.675g in 85g
Labeler: Power Line Packaging, Inc
NDC Code: 63358-101

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.

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 SECTION

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 SECTION

SKIN PROTECTANT

PROTECTOR DE LA PIEL

WARNINGS SECTION

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 SECTION

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 SECTION

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.

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)

INDICATIONS AND USES SECTION

TREATS DIAPER RASH   PROTECTS SKIN  PROMOTES HEALING

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

LANSINOH BABY 
dimethicone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63358-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE4.25 g  in 85 g
LANOLIN (LANOLIN) LANOLIN13.175 g  in 85 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE4.675 g  in 85 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
YELLOW WAX 
LEVOMENOL 
MEDIUM-CHAIN TRIGLYCERIDES 
CHAMOMILE 
GLYCERYL BEHENATE 
JOJOBA OIL 
PETROLATUM 
HYDROGENATED POLYDECENE (550 MW) 
HIGH DENSITY POLYETHYLENE 
STEARYL GLYCYRRHETINATE 
STARCH, CORN 
Packaging
#Item CodePackage Description
1NDC:63358-101-0085 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/2011
Labeler - Power Line Packaging, Inc (181099342)
Registrant - Power Line Packaging, Inc (181099342)
Establishment
NameAddressID/FEIOperations
Power Line Packaging, Inc181099342manufacture

Revised: 08/2011
 
Power Line Packaging, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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