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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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.

Principal Display Panel - Carton Label

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

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 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 finalpart34711/03/2010
Labeler - Laboratorios Andromaco S.A. (980106538)
Registrant - Laboratorios Andromaco S.A. (980106538)
Establishment
NameAddressID/FEIBusiness Operations
Laboratorios Andromaco S.A.980106538manufacture(50145-222)

Revised: 03/2012
Document Id: e89d0c91-1250-4faf-8ac4-be2f685018ca
Set id: 8e486fed-2316-4297-99d3-9b1a7904d0a7
Version: 10
Effective Time: 20120323
 
Laboratorios Andromaco S.A.