DIAPER RASH- zinc oxide cream

Diaper Rash by

Drug Labeling and Warnings

Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Harmon Stores Inc, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Sores, 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)

INGREDIENTS AND APPEARANCE

DIAPER RASH 
zinc oxide cream

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Harmon Stores Inc (804085293)

Registrant - Vi-Jon (790752542)

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