FDA.reportPublic FDA data

Aquaphor Healing Fast Relief Diaper Rash

Manufacturer
Beiersdorf Inc
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:25:56

Label at a glance#

ProductAquaphor Healing Fast Relief Diaper Rash
Active ingredientZINC OXIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 40%

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS & USAGE SECTION

Uses
• helps treat and prevent diaper rash
• protects chafed skin associated with diaper rash and helps protect from wetness

DOSAGE & ADMINISTRATION SECTION

Directions
• change wet and soiled diapers promptly • cleanse the diaper area, and allow to dry • apply ointment cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product • avoid contact with eyes

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help
or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Glycerin, Caprylic/Capric Triglyceride,

Octyldodecanol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate,

Magnesium Stearate, Panthenol,Butyrospermum Parkii (Shea) Butter, Water

OTC - QUESTIONS SECTION

Questions or comments

1-800-227-4703

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aquaphor Healing Paste

Baby

Fast Relief Diaper Rash Paste

Relieves Discomfort in 1 Use

Odor free

Hypoallergenic

Cleans off easily

Paraben and Talc Free

40% Zinc Oxide Skin Protectant

Maximum Strength Formula

aqdiaperrashpastecartonaqdiaperrashpastecarton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10356-115-10Aquaphor Healing Fast Relief Diaper Rash99 g in 1 TUBEOINTMENT998
10356-115-29Aquaphor Healing Fast Relief Diaper Rash4 g in 1 TUBEOINTMENT48

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10356-115-10GM - Gram10356-11570f8c789-c951-4172-b873-0828dfca8e5712022-06-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10356-11510356-115-10, 10356-115-29

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM STEARATE70097M6I30IACT
PANTHENOLWV9CM0O67ZIACT
WATER059QF0KO0RIACT
OCTYLDODECANOL461N1O614YIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
SHEA BUTTERK49155WL9YIACT
ZINC OXIDESOI2LOH54ZACTIB
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aquaphor Healing Fast Relief Diaper RashZINC OXIDEBeiersdorf Inc887e3566-ec5d-4474-83c6-edcc0732f8d62025-12-16WarningsExact identifier
ndc (package): 10356-115-29
ndc (package): 10356-115-10
ndc (product): 10356-115
ndc11 (package): 10356011529
ndc11 (package): 10356011510
spl id: 4615ec4d-f6e0-70c0-e063-6394a90a154f
spl set id: 887e3566-ec5d-4474-83c6-edcc0732f8d6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.