Zinc oxide — v4

Zinc oxide

7 Views

Version

v4

Effective date

September 24, 2025

Original packager

Yes

Sections captured

13

Identifiers

Document ID
3f8bd413-57de-a627-e063-6294a90af14d
Set ID
d56782c1-b23c-47a9-82cb-d7dbb0ac7aa3
Application numbers
M016
Product NDCs
64024-226
Package NDCs
64024-226-26
Original packager NDCs
—

Names & Manufacturers

Brand names
Zinc oxide
Generic names
ZINC OXIDE
Manufacturer names
Aldi, Inc
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
ZINC OXIDE
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
349404
UNII
SOI2LOH54Z
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Zinc oxide 13%
Adverse Reactions (1)

Sequence 1

ADVERSE REACTION DIST. & SOLD EXCLUSIVELY BY: ALDI, INC. 1200 N. Kirk RD. BATAVIA, IL 60510 WWW.ALDI.US. 800-325-7894 MADE IN THE U.S.A. WITH U.S. AND FOREIGN PARTS. ALDI TWICE as Nice GUARANTEE item replaced money refunded PLASTIC TUBE how2recycle.info
Dosage And Administration (1)

Sequence 1

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
Inactive Ingredient (1)

Sequence 1

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
Indications And Usage (1)

Sequence 1

Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

Principal display panel Little Journey™ SKIN PROTECTANT DIAPER RASH OINTMENT zinc oxide MADE WITHOUT PARABANS, PHTHALATES & FRAGRANCE hypoallergenic pediatrician tested dermatologist tested NET WT 4 OZ (113 g) image description
Purpose (1)

Sequence 1

Purpose Skin protectant
Spl Product Data Elements (1)

Sequence 1

Zinc oxide Zinc oxide WATER MINERAL OIL PETROLATUM YELLOW WAX DIMETHICONE SORBITAN SESQUIOLEATE MICROCRYSTALLINE WAX PEG-30 DIPOLYHYDROXYSTEARATE ALOE VERA LEAF GLYCERIN TROPOLONE .ALPHA.-TOCOPHEROL ACETATE 1,2-HEXANEDIOL CAPRYLYL GLYCOL MAGNESIUM SULFATE MONOHYDRATE POTASSIUM HYDROXIDE PHENOXYETHANOL ZINC OXIDE ZINC OXIDE
Stop Use (1)

Sequence 1

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
Storage And Handling (1)

Sequence 1

Other information store between 20º and 25ºC (68º and 77ºF).
Warnings (1)

Sequence 1

Warnings For external use only
When Using (1)

Sequence 1

When using this product do not get into eyes

OpenFDA raw payload

{'application_number': ['M016'],
 'brand_name': ['Zinc oxide'],
 'generic_name': ['ZINC OXIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Aldi, Inc'],
 'package_ndc': ['64024-226-26'],
 'product_ndc': ['64024-226'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'rxcui': ['349404'],
 'spl_id': ['3f8bd413-57de-a627-e063-6294a90af14d'],
 'spl_set_id': ['d56782c1-b23c-47a9-82cb-d7dbb0ac7aa3'],
 'substance_name': ['ZINC OXIDE'],
 'unii': ['SOI2LOH54Z']}