Drugplain

anti itch 1 g/100g

hydrocortisone · OINTMENT · Meijer, Inc.

10 Recalls on RecordCurrently in Shortage
Plain English

anti itch is a ointment containing hydrocortisone at 1 g/100g, taken topical. Manufactured by Meijer, Inc..

Key Facts

Brand Name
anti itch
Generic Name
hydrocortisone
NDC Code (Product)
79481-0471
Manufacturer
Meijer, Inc.
Strength
1 g/100g
Dosage Form
OINTMENT
Route
TOPICAL
Marketing Status
Application #
M017
Drug Class
Corticosteroid [EPC]
Marketing Start
05/05/2021

Recall History

10 Recalls on Record
Class II08/04/2020

Eosera, Inc.

cGMP Deviations.

TerminatedVoluntary: Firm initiated
Class I08/29/2017

Lucky Mart Inc.

Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.

TerminatedVoluntary: Firm initiated
Class II01/27/2017

Cherry Hill Sales Co.

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II08/04/2020

Eosera, Inc.

cGMP Deviations.

TerminatedVoluntary: Firm initiated
Class II04/24/2025

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II04/24/2025

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II12/07/2018

US Pharmaceuticals Inc.

GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample

TerminatedVoluntary: Firm initiated
Class II07/11/2019

US Pharmaceuticals Inc.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

TerminatedVoluntary: Firm initiated
Class II07/11/2019

US Pharmaceuticals Inc.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

TerminatedVoluntary: Firm initiated
Class II07/11/2019

US Pharmaceuticals Inc.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use10,514 reports
drug ineffective9,388 reports
fatigue7,905 reports
condition aggravated6,564 reports
pain6,496 reports
rash6,470 reports
nausea6,202 reports
headache5,688 reports
arthralgia5,564 reports
dyspnoea5,534 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • temporarily relieves 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 • temporarily relieves external anal and genital itching • other uses of this product should only be under the advice and supervision of a doctor

Dosage & Administration

Directions • for itching of skin irritation, inflammation, and rashes: • 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, ask a doctor • for external anal and genital itching, adults: • when practical, clean the affected area with mild soap and warm water and rinse thoroughly • gently dry by patting or blotting with toilet tissue or a soft cloth before applying • apply to affected area not more than 3 to 4 times daily • children under 12 years of age: ask a doctor

Warnings

Warnings For external use only Do not use • in the genital area if you have a vaginal discharge. Consult a doctor. • for the treatment of diaper rash. Consult a doctor. When using this product • avoid contact with the eyes • do not use more than directed unless told to do so by a doctor • do not put directly into the rectum by using fingers or any mechanical device or applicator 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, and do not begin use of any other hydrocortisone product unless you have asked a doctor • rectal bleeding occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Frequently Asked Questions

What is anti itch used for?

anti itch contains hydrocortisone. It is a ointment taken topical. Consult your doctor for specific uses.

Is anti itch a controlled substance?

anti itch is not classified as a controlled substance by the DEA.

What is the generic name for anti itch?

The generic name for anti itch is hydrocortisone. There are 12 other brand versions of hydrocortisone.

What is the NDC code for anti itch 1 g/100g?

The NDC (National Drug Code) for anti itch 1 g/100g is 79481-0471, listed by Meijer, Inc..