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Diaper Rash by Harmon Stores Inc

Dosage form: cream
Ingredients: ZINC OXIDE 130mg in 1g
Labeler: Harmon Stores Inc
NDC Code: 63940-226

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.

Drug Facts

Active ingredient

Zinc oxide 13%

Purpose

Skin protectant

Use
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only

When using this product
  • do not get into eyes

Stop use
  • condition worsens
  • 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
  • change wet and soiled diaper promplty
  • cleanse the diaper area
  • allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

store between 20º and 25ºC (68º and 77º F)

Inactive ingredients

aloe barbadensis leaf juice, beeswax, dimethicone, ethylhexylglycerin, fragrance, magnesium sulfate, methylparaben, microcrystalline wax, mineral oil, PEG-30 dipolyhydroxystearate, petrolatum, phenoxyethanol, potassium hydroxide, propylparaben, sorbitan sesquioleate, tocopheryl acetate, water

Disclaimer

This product is not manufactured or distriubted by the Johnson & Johnson Consumer Products Company, distriubtor of Desitin Rapid Relief Zinc Diaper Rash Cream

Made in the USA with US and imported parts

Adverse Reactions

Distributed by

Harmon Sores, Inc

650 Liberty Ave

Union, NJ 07083 UA

Harmon Stores, Inc

Visit us at: www.facevalue.com

226.001/226AC

Principal Display Panel

PEDIATRICIAN 

TESTED

HARMON

FACEVALUES

Compare Ours

to Desitin Rapid Relief

Diaper

Rash

Creamy

Zinc Oxide

Diaper Rash

Cream

Skin Protectant

HELPS SOOTHE, HEAL & PREVENT DIAPER RASH

NETWT 4 OZ (113g)

DIAPER RASH 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-226
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE130 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
YELLOW WAX 
DIMETHICONE 
ETHYLHEXYLGLYCERIN 
MAGNESIUM SULFATE MONOHYDRATE 
MICROCRYSTALLINE WAX 
MINERAL OIL 
PEG-30 DIPOLYHYDROXYSTEARATE 
PETROLATUM 
PHENOXYETHANOL 
POTASSIUM HYDROXIDE 
SORBITAN SESQUIOLEATE 
.ALPHA.-TOCOPHEROL ACETATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:63940-226-261 TUBE in 1 CARTON
1113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/15/2013
Labeler - Harmon Stores Inc (804085293)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(63940-226)

Revised: 03/2017
 
Harmon Stores Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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