Hipoglos

Dosage form: ointment
Ingredients: ZINC OXIDE 15g in 100g, LANOLIN 15g in 100g
Labeler: Laboratorios Andromaco S.A.
NDC Code: 50145-222

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.

Hipoglós® Ointment

Active ingredient

Lanolin USP 15%

Zinc Oxide 15%

Purpose

Skin Protectant

Uses
  • Helps treat and prevent diaper rash.
  • Protects chafed skin due to diaper rash.
  • Helps seal out wetness.

Warnings

For external use only

When using this product - do not get into eyes

Stop use and ask a doctor if:

  • Conditions worsen.
  • Symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on:

  • Deep or puncture wounds
  • Animal Bites
  • Serious Burns

Keep out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Change wet or soiled diapers promptly.
  • Clean 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.

Other Information

Store at 59° to 86° F (15 ° to 30° C)

Inactive ingredients

Alcohol, Benzethonium Chloride, Cod Liver Oil (contains vitamin A and D), Lavender Fragrance, Mineral Oil, Petrolatum, Sorbitan Monostearate, Talc, Vanillin, and Water.

Propósito

Protector dérmico

Usos
  • Ayuda a tratar y prevenir las irritaciones producidas por el pañal.
  • Protege la piel irritada debido a las rozaduras de pañal.
  • Ayuda a mantener la piel seca.

Warnings

Para uso externo
*Cuando use este producto no aplicar en los ojos.

Descontinuar su uso y preguntar al médico si:
• la condición empeora
• Los síntomas permanecen por más de 7 días o si desaparecen y vuelven a aparecer luego de pocos días.

No usar en:
• Heridas profundas y punzantes.
• Mordeduras de animales
• Quemaduras graves

Mantener fuera del alcance de los niños

* Si son ingeridos, consiga ayuda médica o acuda al Centro de Control de Envenenamiento inmediatamente.

Indicaciones de uso
  • Cambiar pañales mojados o sucios rápidamente.
  • Limpie la zona del pañal.
  • Deje secar.
  • Aplicar ungüento libremente de acuerdo a necesidad, con cada muda del pañal, especialmente a la hora de dormir o cuando la exposición a pañales mojados se prolongue más de lo habitual.

Otra información

*Almacenar entre 59° y 86° F (15 y 30°C).

Excipientes

alcohol, cloruro de bencetonio, aceite de hígado de bacalao (contiene vitaminas A y D), esencia de lavanda, aceite mineral, petrolato blanco, monoestearato de sorbitan, talco, vainillina, agua.

Principal Display Panel - Carton Label

Carton Label

Hipoglós® Ointment

Helps prevent and treat diaper rash, skin irritation

Net wt. 4.2 oz (120 g)

Principal Display Panel - Tube Label

Tube Label

Hipoglós® Ointment

Helps prevent and treat diaper rash, skin irritation

Net wt. 4.2 oz (120 g)

HIPOGLOS 
zinc oxide and lanolin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50145-222
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE15 g  in 100 g
LANOLIN (LANOLIN) LANOLIN15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
BENZETHONIUM CHLORIDE 
COD LIVER OIL 
ENGLISH LAVENDER OIL 
MINERAL OIL 
PETROLATUM 
SORBITAN MONOSTEARATE 
TALC 
VANILLIN 
WATER 
Packaging
#Item CodePackage Description
1NDC:50145-222-011 TUBE (TUBE) in 1 CARTON
1120 g in 1 TUBE
2NDC:50145-222-021 TUBE (TUBE) in 1 CARTON
2100 g in 1 TUBE
3NDC:50145-222-031 TUBE (TUBE) in 1 CARTON
372 g in 1 TUBE
4NDC:50145-222-041 TUBE (TUBE) in 1 CARTON
460 g in 1 TUBE
5NDC:50145-222-051 TUBE (TUBE) in 1 CARTON
55 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/03/2010
Labeler - Laboratorios Andromaco S.A. (980106538)
Registrant - Laboratorios Andromaco S.A. (980106538)
Establishment
NameAddressID/FEIOperations
Laboratorios Andromaco S.A.980106538manufacture(50145-222)

Revised: 11/2013
 
Laboratorios Andromaco S.A.

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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