HIPOGLOS- zinc oxide and lanolin ointment 
Laboratorios Andromaco S.A.

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.

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Hipoglós® Ointment

Active ingredient

Lanolin USP 15%

Zinc Oxide 15%

Purpose

Skin Protectant

Uses

Warnings

For external use only

When using this product - do not get into eyes

Stop use and ask a doctor if:

Do not use on:

Keep out of reach of children

Directions

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

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

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

Principal Display Panel - Carton Label

Hipoglós® Ointment

Helps prevent and treat diaper rash, skin irritation

Net wt. 4.2 oz (120 g)

Principal Display Panel - Tube Label

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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 g
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
COD LIVER OIL (UNII: BBL281NWFG)  
ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
TALC (UNII: 7SEV7J4R1U)  
VANILLIN (UNII: CHI530446X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50145-222-011 in 1 CARTON
1120 g in 1 TUBE
2NDC:50145-222-021 in 1 CARTON
2100 g in 1 TUBE
3NDC:50145-222-031 in 1 CARTON
372 g in 1 TUBE
4NDC:50145-222-041 in 1 CARTON
460 g in 1 TUBE
5NDC:50145-222-051 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/FEIBusiness Operations
Laboratorios Andromaco S.A.980106538manufacture(50145-222)

Revised: 11/2013
Document Id: 62bb10cd-4e99-4e93-a7f5-9dabf692a2d6
Set id: 8e486fed-2316-4297-99d3-9b1a7904d0a7
Version: 12
Effective Time: 20131102
 
Laboratorios Andromaco S.A.