Drugplain

Itch Relief 1 g/100g

Hydrocortisone 1% · CREAM · Trifecta Pharmaceuticals USA LLC

9 Recalls on RecordCurrently in Shortage
Plain English

Itch Relief is a cream containing hydrocortisone 1% at 1 g/100g, taken topical. Manufactured by Trifecta Pharmaceuticals USA LLC.

Key Facts

Brand Name
Itch Relief
Generic Name
Hydrocortisone 1%
NDC Code (Product)
69396-057
Manufacturer
Trifecta Pharmaceuticals USA LLC
Strength
1 g/100g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M017
Drug Class
Corticosteroid [EPC]
Marketing Start
09/15/2020

Recall History

9 Recalls on Record
Class II06/29/2022

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations: products were stored outside the drug label specifications.

TerminatedVoluntary: Firm initiated
Class II01/16/2014

The Mentholatum Co.

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

TerminatedVoluntary: Firm initiated
Class II06/29/2022

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations: products were stored outside the drug label specifications.

TerminatedVoluntary: Firm initiated
Class II08/09/2019

Ridge Properties, LLC

Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.

TerminatedVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
Class II09/03/2020

Akorn, Inc.

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II02/23/2023

Teva Pharmaceuticals USA Inc

Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.

TerminatedVoluntary: Firm initiated
Class II08/09/2019

Ridge Properties, LLC

Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use15,517 reports
drug ineffective15,332 reports
fatigue12,695 reports
nausea11,329 reports
pain10,990 reports
headache10,522 reports
dyspnoea9,111 reports
diarrhoea8,773 reports
arthralgia8,569 reports
rash8,243 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses ■ for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: ■ eczema ■ psoriasis ■ poison ivy, oak, sumac ■ insect bites ■ detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis ■ other uses of this product should be only under the advice and supervision of a doctor

Dosage & Administration

D irections ■ adults and children 2 years of age and older : apply to affected area. Do not use more than 3 to 4 times daily. ■ children under 2 years of age: do not use, ask a doctor.

Warnings

Warnings For external use only . Flam mable. Keep away from fire or flame. Do not us e ■ for the treatment of diaper rash. Consult a doctor. ■ if you are allergic to any ingredient in this product. When using this product ■ avoid contact with the eyes ■ contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120° F. ■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. ■ do not use more than directed unless told to do so by a doctor Stop use and ask a doctor if ■ condition worsens ■ symptoms persist for more than 7 days or clear up and occur again within a few days, do not use this or any other hydrocortisone product unless you have asked a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Itch Relief used for?

Itch Relief contains Hydrocortisone 1%. It is a cream taken topical. Consult your doctor for specific uses.

Is Itch Relief a controlled substance?

Itch Relief is not classified as a controlled substance by the DEA.

What is the generic name for Itch Relief?

The generic name for Itch Relief is Hydrocortisone 1%. There are 11 other brand versions of Hydrocortisone 1%.

What is the NDC code for Itch Relief 1 g/100g?

The NDC (National Drug Code) for Itch Relief 1 g/100g is 69396-057, listed by Trifecta Pharmaceuticals USA LLC.