FDA.reportPublic FDA data

Quality Choice Anti-Itch Cream with Aloe

Manufacturer
Chain Drug Marketing Association Inc. | Trifecta Pharmaceuticals USA, LLC.
Effective date
2023-05-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:55:02

Label at a glance#

ProductAnti-Itch with Aloe
Active ingredientHYDROCORTISONE
Label structure12 sections

Dosage and administration

Adults and children 2 years and older apply to affected area not more than 3 to 4 times daily. Children under 2 years of age do not use, consult doctor For external and anal itching adults when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age with ext...

Storage and handling

Store at controlled room temperature 20º-25ºC (68º-77ºF)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-Itch

INDICATIONS & USAGE SECTION

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

  • insect bites
  • eczema
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • external feminine genital and anal itching
  • Other uses of this product should be only under the advice and supervision of a doctor.

Warnings

WARNINGS SECTION

For External Use Only

Do not use for the treatment of diaper rash, consult a doctor.

For external genital itching if you have a vaginal discharge, consult a doctor.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • Conditions worsen
  • Symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately

Other information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 20º-25ºC (68º-77ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera (Aloe Barbadensis) leaf juice, Cetostearyl alcohol, Edatate Disodium, Glyceryl monostearate, Methylparaben, Mineral Oil, White Petrolatum, Propylene glycol, Purified Water, Sorbitan Monostearate, Polysorbate 60

When using this product

WARNINGS SECTION

  • Avoid contact with the eyes
  • do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
  • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In the case of bleeding, stop use, consult a doctor.
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and older

  • apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age

  • do not use, consult doctor

For external and anal itching

  • adults when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • Children under 12 years of age with external anal ithcing consult a doctor.

Distributed By

SPL UNCLASSIFIED SECTION

Distributed By CDMA Inc.

43157 W 9 Mile Rd.

Novi, MI. 48375

www.qualitychoice.com

Questions: 800-935-2362

Product PRC

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

qc anti itch cream aloe 1ozqc anti itch cream aloe 1oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN3
106258hydrocortisone 10 MG/ML Topical CreamSCD3
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY3
106258hydrocortisone 1 % Topical CreamSY3
106258hydrocortisone 1 GM per 100 GM Topical CreamSY3

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-688-012025-01-30C16284748780-1f386c64a-00a7-0266-e053-dadaa90a7c1aQuality Choice Anti-Itch Cream with Aloe
63868-688-012023-05-23C16284748780-1f386c64a-00a7-0266-e053-dadaa90a7c1aQuality Choice Anti-Itch Cream with Aloe
63868-688-012023-01-30C16284748780-1f386c64a-00a7-0266-e053-dadaa90a7c1aQuality Choice Anti-Itch Cream with Aloe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-688-01Anti-Itch with Aloe1 in 1 BOXCREAM13
63868-688-01Anti-Itch with Aloe28.3 g in 1 TUBECREAM28.33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-688ANTI-ITCH WITH ALOE (HYDROCORTISONE 1%) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC.]3Legacy NDC, 2 package rows20230524_acc79e55-fa58-2915-e053-2a95a90a0101.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-68863868-688-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITAN MONOSTEARATENVZ4I0H58XIACT
ALOE VERA LEAFZY81Z83H0XIACT
EDETATE DISODIUM7FLD91C86KIACT
POLYSORBATE 60CAL22UVI4MIACT
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROCORTISONEWI4X0X7BPJACTIB

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
fc5f2212-8ecc-e4c8-e053-6394a90a7483acc79e55-fa58-2915-e053-2a95a90a01012023-05-23WarningsExact identifier
spl id: fc5f2212-8ecc-e4c8-e053-6394a90a7483
spl set id: acc79e55-fa58-2915-e053-2a95a90a0101

Reported adverse events (FAERS/openFDA)#

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