FDA.reportPublic FDA data

Aquaphor Itch Relief Ointment

Manufacturer
Beiersdorf Inc
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:25:57

Label at a glance#

ProductAquaphor Itch Relief
Active ingredientHYDROCORTISONE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Hydrocortisone 1%

OTC - PURPOSE SECTION

Purpose

Anti-Itch Ointment

INDICATIONS & USAGE SECTION

Uses

• for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

• eczema
• insect bites
• soaps
• poison ivy, oak, sumac
• seborrheic dermatitis
• psoriasis
• detergents
• cosmetics
• jewelry

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use
• for the treatment of diaper rash. Consult a doctor.

OTC - WHEN USING SECTION

When using this product
• avoid contact with eyes
• do not exceed the recommended daily dosage unless directed by a doctor

OTC - STOP USE SECTION

Stop use and consult a doctor if
• condition worsens, if symptoms persist for more than 7 days or clear
up and occur again within a few days,

and do not begin use of any other hydrocortisone product unless you have asked a doctor

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.

DOSAGE & ADMINISTRATION SECTION

Directions
Adults and children 2 years of age and older:
• Apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: Do not use, consult a doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Petrolatum, Mineral Oil, Ceresin, Lanolin Alcohol,
Panthenol, Glycerin, Bisabolol, Menthoxypropanediol

OTC - QUESTIONS SECTION

Questions or comments?
1-800-227-4703

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aquaphor Itch Relief Ointment

Maximum Strength

Immediately Soothes & Relieves Itch & Irritiation

Up to 12 hours Significant Itch Relief

Clinically Proven

1% Hydrocortisone Anti-Itch Ointment

Dermatologist Recommended Brand

Fragrance free and Paraben free

Hypoallergenic

Helps Heal the Itch

Clinically proven significant itch relief for up to 12 hours

Immediately soothes itchy spots to help skin heal

Skin irritation

Skin rashes

Eczema

Psoriasis

Eczema

Poison Ivy

aqitchreliefcartonaqitchreliefcarton

Children's

Aquaphor Itch Relief Ointment

Ages 2 Years and Older

Immediately Soothes & Relieves Itch & Irritiation

Up to 12 hours Significant Itch Relief

Clinically Proven

Number 1 Pediatrician Recommended Brand for Eczema

1% Hydrocortisone Anti-Itch Ointment

Dermatologist Recommended Brand

Fragrance free and Paraben free

Hypoallergenic

Helps Heal the Itch

Clinically proven significant itch relief for up to 12 hours

Immediately soothes itchy spots to help skin heal

Eczema

Skin irritation

Skin rashes

Psoriasis

Eczema

Poison Ivy

aqchilditchreliefcartonaqchilditchreliefcarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2462510Aquaphor Itch Relief 1 % Topical OintmentPSN6
203105hydrocortisone 1 % Topical OintmentPSN6
2462510hydrocortisone 0.01 MG/MG Topical Ointment [Aquaphor Itch Relief]SBD6
203105hydrocortisone 0.01 MG/MG Topical OintmentSCD6
2462510Aquaphor Itch Relief 0.01 MG/MG Topical OintmentSY6
2462510Aquaphor Itch Relief 1 % Topical OintmentSY6
203105hydrocortisone 1 % Topical OintmentSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10356-120-04Aquaphor Itch Relief28 g in 1 TUBEOINTMENT286
10356-120-07Aquaphor Itch Relief56 g in 1 TUBEOINTMENT566
10356-120-30Aquaphor Itch Relief0.9 g in 1 PACKETOINTMENT0.96
10356-120-52Aquaphor Itch Relief1 in 1 CARTONOINTMENT16
10356-120-53Aquaphor Itch Relief2 in 1 CARTONOINTMENT26
10356-120-54Aquaphor Itch Relief1 in 1 CARTONOINTMENT16

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
10356-12010356-120-30, 10356-120-04, 10356-120-52, 10356-120-53, 10356-120-07, 10356-120-54

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
HYDROCORTISONEWI4X0X7BPJACTIB
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOLKD6TZ2QICHIACT
MINERAL OILT5L8T28FGPIACT
CERESINQ1LS2UJO3AIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
GLYCERINPDC6A3C0OXIACT
PANTHENOLWV9CM0O67ZIACT
LEVOMENOL24WE03BX2TIACT
PETROLATUM4T6H12BN9UIACT

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 Itch ReliefHYDROCORTISONEBeiersdorf Incb1d0333f-ba60-35d8-e053-2995a90af9322025-12-16WarningsExact identifier
ndc (package): 10356-120-52
ndc (package): 10356-120-30
ndc (package): 10356-120-07
ndc (package): 10356-120-53
ndc (package): 10356-120-04
ndc (package): 10356-120-54
ndc (product): 10356-120
ndc11 (package): 10356012030
ndc11 (package): 10356012052
ndc11 (package): 10356012054
ndc11 (package): 10356012053
ndc11 (package): 10356012007
ndc11 (package): 10356012004
spl id: 4615f353-0a2d-5ff1-e063-6394a90a77e3
spl set id: b1d0333f-ba60-35d8-e053-2995a90af932

Reported adverse events (FAERS/openFDA)#

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