FDA.reportPublic FDA data

Alocane Anti-Itch

Manufacturer
Quest Products, LLC | Tec Laboratories, LLC
Effective date
2026-02-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:46:27

Label at a glance#

ProductAlocane Anti-Itch
Active ingredientHYDROCORTISONE
Label structure8 sections

Indications and uses

For the temporary relief of itching associated with minor skin irritations, inflamation, and rashes due to eczema insect bites poison ivy, poison oake, or poison sumac soaps detegents cosmetics jewelry seborrheic dermatitis psoriasis and for external genital, feminine, and anal itching

Dosage and administration

Adults and Children 2 years of age or older Apply to affected area not more than 3 to 4 times daily. Adults: when practical, cleans the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product. Children under 2 years of age: Do not use, consult a doctor. For external anal itching: Adults: when practical c...

Storage and handling

Store at room temperature 15° - 30° C (59° - 86°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-Itch

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of itching associated with minor skin irritations, inflamation, and rashes due to

  • eczema
  • insect bites
  • poison ivy, poison oake, or poison sumac
  • soaps
  • detegents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • and for external genital, feminine, and anal itching

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY

When using this product avoid contact with eyes

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Do not use

OTC - DO NOT USE SECTION

  • for the treatment of diaper rash
  • Do not use if you have vaginal discharge. Consult a doctor.
  • Do not exceed the recommended daily dosage unless directed by a doctor.
  • In case of bleeding, consult a doctor promptly.
  • Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Kep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center reight away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children 2 years of age or older

  • Apply to affected area not more than 3 to 4 times daily.
  • Adults: when practical, cleans the affected area with mild soap and warm water and rinse thoroughly.
  • Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product.

Children under 2 years of age: Do not use, consult a doctor.

For external anal itching:

  • Adults: when practical cleanse the affected area with mild soap and warm water and rinse thoroughly.
  • Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product.

Children Under 12 years of age: consult a doctor.

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature 15° - 30° C (59° - 86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Ethylhexylglycerin, Hypromellose, Phenoxyethanol, Propanediol, SD Alcohol 40-B, Water.

1.5oz Outer labeL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2728413ALOCANE Anti-Itch 1 % Topical GelPSN2
198706hydrocortisone 1 % Topical GelPSN2
2728413hydrocortisone 0.01 MG/MG Topical Gel [Alocane Anti-Itch]SBD2
198706hydrocortisone 0.01 MG/MG Topical GelSCD2
2728413Alocane Anti-Itch 1 % Topical GelSY2
198706hydrocortisone 1 % Topical GelSY2

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
68229-411-01Alocane Anti-Itch70.8 g in 1 TUBEGEL70.82
68229-411-02Alocane Anti-Itch1 in 1 CARTONGEL12
68229-411-03Alocane Anti-Itch42.5 g in 1 TUBEGEL42.52
68229-411-04Alocane Anti-Itch1 in 1 CARTONGEL12

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
68229-41168229-411-01, 68229-411-02, 68229-411-03, 68229-411-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
HYDROCORTISONEWI4X0X7BPJACTIB
ALCOHOL3K9958V90MIACT
PROPANEDIOL5965N8W85TIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-12-04monthly-update2026-06-03 17:45:22

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
Alocane Anti-ItchHYDROCORTISONE 1%Quest Products, LLC45252043-d41a-3cdd-e063-6394a90aa9e52026-02-18WarningsExact identifier
ndc (package): 68229-411-03
ndc (package): 68229-411-02
ndc (package): 68229-411-01
ndc (package): 68229-411-04
ndc (product): 68229-411
ndc11 (package): 68229041101
ndc11 (package): 68229041103
ndc11 (package): 68229041102
ndc11 (package): 68229041104
spl id: 4b235f6d-d684-e3a3-e063-6294a90a02fa
spl set id: 45252043-d41a-3cdd-e063-6394a90aa9e5

Reported adverse events (FAERS/openFDA)#

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