DIAPER RASH- zinc oxide paste

Diaper Rash by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

PEDITRICIA TESTED

HELPS SOOTHE, HEAL & PREVENT DIAPER RASH

Skin Protectant

NET WT 4 OZ (113 g)

INGREDIENTS AND APPEARANCE

DIAPER RASH 
zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	532 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
COD LIVER OIL (UNII: BBL281NWFG)
STARCH, CORN (UNII: O8232NY3SJ)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
YELLOW WAX (UNII: 2ZA36H0S2V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-020-26	1 in 1 CARTON	03/05/2013
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 final	part347	03/05/2013

Labeler - Harmon Stores, Inc (804085293)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-jon		790752542	manufacture(63940-020)

Establishment
Name	Address	ID/FEI	Business Operations
Memphis Contract Packaging		185390010	manufacture(63940-020)