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NDC 00363-1020-26 Zinc Oxide 532 mg/g Details

Zinc Oxide 532 mg/g

Zinc Oxide is a TOPICAL PASTE in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Co. The primary component is ZINC OXIDE.

Product Information

NDC	00363-1020
Product ID	0363-1020_80f5fc76-4df7-4ff4-b457-4ff16adfb429
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Zinc Oxide
Proprietary Name Suffix	n/a
Non-Proprietary Name	ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE
Route	TOPICAL
Active Ingredient Strength	532
Active Ingredient Units	mg/g
Substance Name	ZINC OXIDE
Labeler Name	Walgreen Co
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-1020-26 (00363102026)

Pricing Information	N/A
NDC Package Code	0363-1020-26
Billing NDC	00363102026
Package	1 TUBE in 1 PACKAGE (0363-1020-26) / 113 g in 1 TUBE
Marketing Start Date	2008-03-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 220f70e1-0802-4fe2-92d0-78dec557c993 Details

Active ingredient

Zinc oxide 40%

Purpose

Skin Protectant

Uses

• helps treat and prevent diaper rash

• protects chafed skin due to the 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 soiled diapers promptly

• 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 20⁰ and 25⁰C (68⁰ and 77⁰F)

Inactive ingredients

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

Questions?

Call 1-800-925-4733

SPL UNCLASSIFIED SECTION

Distributed by Walgreen Co.

200 Wilmot Rd., Deerfield, IL 60015

Walgreens Pharmacist Recommended Walgreens Pharmacist Survey

principal display panel

Baby diaper rash paste

Zinc oxide 40%/Skin protectant

Maximum strength

Paraben free

Helps promote healing & soothes diaper rash

Thick, rich formula

Does not contain talc

NET WT 4 OZ (113 g)

INGREDIENTS AND APPEARANCE

ZINC OXIDE

zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-1020
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	532 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)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-1020-26	1 in 1 PACKAGE	03/24/2008
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	03/24/2008

Labeler - Walgreen Co (008965063)

Registrant - Vi Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		790752542	manufacture(0363-1020)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(0363-1020)

Revised: 4/2022

Document Id: 80f5fc76-4df7-4ff4-b457-4ff16adfb429

Set id: 220f70e1-0802-4fe2-92d0-78dec557c993

Version: 14

Effective Time: 20220426