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Diaper Rash by Harmon Stores, Inc

Medically reviewed on February 23, 2018

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

petrolatum, cod liver oil, lanolin, Zea mays (corn) starch, glycerin, sorbitan sesquioleate, beeswax, tocopheryl acetate, fragrance

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

020.002/020AC

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
PETROLATUM 
COD LIVER OIL 
STARCH, CORN 
GLYCERIN 
SORBITAN SESQUIOLEATE 
YELLOW WAX 
.ALPHA.-TOCOPHEROL ACETATE 
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)

 
Harmon Stores, Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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