DIAPER- zinc oxide ointment 
Medek Laboratories Inc.

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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Drug Facts

Active Ingredients                                                               Purpose

Zinc Oxide 12.8%..............................................................Skin Protectant

Purpose

Skin Protectant

Warnings

FOR EXTERNAL USE ONLY

When using this product

When using this product keep out of eyes.

Stop use and ask a doctor if

Stop use and ask a doctor if condition worsens or does not improve after 7 days

Keep out of reach of children

Keep out of reach of children.

Other Information

protect this product from excessive heat and direct sun

Inactive Ingredients

Petrolatum, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, camellia sinensis leaf extract, tocopheryl acetate, sunflower seed extract, sorbitan oleate, bisabolol, cholesterol

Indications

Uses

Help heal and prevent diaper rash

Protects chafed skin due to diaper rash and helps protect wetness

Do Not Use

Discontinue use if irritation occurs.

Ask a doctor

Ask a doctor if condition worsens

Directions

change wet and soiled diapers promptly

cleanse the diaper area

allow to dry

apply ointment liberally as often as necessary with each diaper change and anytime when exposure to wet diapers may be prolonged

dosage

apply ointment liberally as often as necessary with each diaper change and anytime when exposure to wet diapers may be prolonged

image of label

image of label

DIAPER 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71969-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION21.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
STARCH, CORN (UNII: O8232NY3SJ)  
LANOLIN (UNII: 7EV65EAW6H)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
TOCOL ACETATE (UNII: 37Z972M0N0)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
BISABOLOL OXIDE A (UNII: 16AE65F94Y)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71969-111-01170 g in 1 JAR; Type 0: Not a Combination Product03/08/2018
2NDC:71969-111-021 in 1 PACKAGE04/09/2018
257 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/08/2018
Labeler - Medek Laboratories Inc. (080332132)

Revised: 12/2019
Document Id: 18a86497-ef3a-499a-aded-5145514ddfaa
Set id: 38d66ea2-4c95-4a7c-88ca-d74a6d972228
Version: 4
Effective Time: 20191203
 
Medek Laboratories Inc.