DIAPER RASH- zinc oxide cream
Harmon Stores 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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Harmon 226.002 226AD

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

water, mineral oil, petrolatum, beeswax, dimethicone, sorbitan sesquioleate, microcrystalline wax, PEG-30 dipolyhydroxystearate, Aloe barbadensis leaf juice, glycerin, tropolone, tocopheryl acetate, 1,2-hexanediol, caprylyl glycol, magnesium sulfate, potassium hydroxide, phenoxyethanol

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 Stores, Inc

650 Liberty Ave

Union, NJ 07083 UA

Harmon Stores, Inc

Visit us at: www.facevalue.com

226.002/226AD

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)

image description

DIAPER RASH
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63940-226
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	130 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
YELLOW WAX (UNII: 2ZA36H0S2V)
DIMETHICONE (UNII: 92RU3N3Y1O)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
TROPOLONE (UNII: 7L6DL16P1T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MAGNESIUM SULFATE MONOHYDRATE (UNII: E2L2TK027P)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63940-226-26	1 in 1 CARTON	02/15/2013	06/17/2020
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/15/2013	06/17/2020

Labeler - Harmon Stores Inc (804085293)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(63940-226)

Revised: 6/2020

Document Id: 5320efd5-a2e8-47fe-b0fb-0f41724de669

Set id: e4f698fe-88f9-4ee0-825f-45502b6f0fe4

Version: 8

Effective Time: 20200617

Harmon Stores Inc