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Diaper Rash by Harmon Stores, Inc

Dosage form: paste
Ingredients: ZINC OXIDE 532mg in 1g
Labeler: Harmon Stores, Inc
NDC Code: 63940-020

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 Ingredients

Zinc oxide 40%

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 and ask a doctor if
  • 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 soilded diapers promptly
  • cleanse the diaper area
  • allow to dry
  • apply paste 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 20⁰ and 25⁰C (68⁰ and 77⁰F)

Inactive ingredients

BHA, cod liver oil, fragance, lanolin, petrolatum, phenoxyethanol, talc, water

Adverse Reactions 

Dist. by Harmon Stores, Inc.

650 Liberty Ave.

Union, MJ 07083 USA

Visit us at: www.facevalues.com

Made in the USA with U.S. and imported parts

Principal Display Panel

HARMON

FACEVALUES

DIAPER RASH

PASTE 40% zinc oxide diaper rash paste

Skin Protectant

PEDIATRICIA TESTED

HELPS SOOTHE, HEAL + PREVENT DIAPER RASH

NET WT 4 OZ (113 g)

DIAPER RASH 
zinc oxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-020
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC CATION) ZINC CATION532 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
COD LIVER OIL 
LANOLIN 
petrolatum 
PHENOXYETHANOL 
TALC 
WATER 
Packaging
#Item CodePackage Description
1NDC:63940-020-261 TUBE in 1 CARTON
1113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/05/2013
Labeler - Harmon Stores, Inc (804085293)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-jon790752542manufacture(63940-020)
Establishment
NameAddressID/FEIOperations
Memphis Contract Packaging185390010manufacture(63940-020)

Revised: 09/2013
 
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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