HIPOGLOS- zinc oxide and lanolin ointment

Hipoglos by

Drug Labeling and Warnings

Hipoglos by is a Otc medication manufactured, distributed, or labeled by Laboratorios Andromaco S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

HIPOGLOS 
zinc oxide and lanolin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50145-222
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 g  in 100 g
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50145-222-01	1 in 1 CARTON
1		120 g in 1 TUBE
2	NDC: 50145-222-02	1 in 1 CARTON
2		100 g in 1 TUBE
3	NDC: 50145-222-03	1 in 1 CARTON
3		72 g in 1 TUBE
4	NDC: 50145-222-04	1 in 1 CARTON
4		60 g in 1 TUBE
5	NDC: 50145-222-05	1 in 1 CARTON
5		5 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/03/2010

Labeler - Laboratorios Andromaco S.A. (980106538)

Registrant - Laboratorios Andromaco S.A. (980106538)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratorios Andromaco S.A.		980106538	manufacture(50145-222)