DIAPER RASH- zinc oxide paste
Liberty Procurement, 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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Diaper Rash Ointment 40% Zinc Oxide
020.002/AC-AD

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

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)

image description

DIAPER RASH
zinc oxide paste

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	400 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
COD LIVER OIL (UNII: BBL281NWFG)
LANOLIN (UNII: 7EV65EAW6H)
STARCH, CORN (UNII: O8232NY3SJ)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
YELLOW WAX (UNII: 2ZA36H0S2V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63940-020-26	1 in 1 CARTON	03/05/2013	03/04/2021
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 final	part347	03/05/2013	03/04/2021

Labeler - Liberty Procurement, Inc (804085293)

Registrant - Vi-Jon, LLC (790752542)

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

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(63940-020)

Revised: 5/2023

Document Id: cfcab2fd-3d9a-4988-ba94-639cd8e3c2bc

Set id: a5fe7fd8-54a2-4fa3-9da6-fea7f460c472

Version: 23

Effective Time: 20230501

Liberty Procurement, Inc

Diaper Rash Ointment 40% Zinc Oxide020.002/AC-AD