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

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Hipoglós® Ointment

Active ingredient

Lanolin USP 28%

Zinc Oxide 15%

Purpose

Skin Protectant

Uses

• Helps treat and prevent severe diaper rash.
• Temporarily protects and helps relieve chapped or irritated skin (and lips), minor cuts, scrapes and burns.
• Moisturizes while helping to 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.

Keep out of reach of children

• If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply as needed.
• Change wet and soiled diapers immediately.
• Cleanse diaper area and allow to dry.
• Apply liberally as often as necessary.
• Store between 15 and 30° C.

Inactive ingredients

Benzethonium Chloride, Cod Liver Oil (contains vitamin A and D), Lavender Oil, Mineral Oil, Petrolatum, Talc, Vanillin, Sorbitan Monostearate, Alcohol 96° and Water.

Principal Display Panel - Carton Label

Hipoglós® Ointment

Helps prevent and treat diaper rash, skin irritation

Net wt. 3.5 oz (100 g)

HIPOGLOS  zinc oxide and lanolin   ointment

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 50145-111 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 15 g  in 100 g LANOLIN (LANOLIN) LANOLIN 28 g  in 100 g

Inactive Ingredients Ingredient Name Strength BENZETHONIUM CHLORIDE   COD LIVER OIL   ENGLISH LAVENDER OIL   MINERAL OIL   PETROLATUM   TALC   VANILLIN   SORBITAN MONOSTEARATE   ALCOHOL   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50145-111-01 1 TUBE In 1 CARTON contains a TUBE, WITH APPLICATOR 1 120 g In 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (50145-111-01) 2 50145-111-02 1 TUBE In 1 CARTON contains a TUBE, WITH APPLICATOR 2 100 g In 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (50145-111-02) 3 50145-111-03 1 TUBE In 1 CARTON contains a TUBE, WITH APPLICATOR 3 72 g In 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (50145-111-03) 4 50145-111-04 1 TUBE In 1 CARTON contains a TUBE, WITH APPLICATOR 4 60 g In 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (50145-111-04)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/03/2010

Labeler - Laboratorios Andromaco S.A. (980106538)

Revised: 11/2010Laboratorios Andromaco S.A.