Itch Relief 20.3 g/L

diphenhydramine hydrochloride · LIQUID · Safetec of America, Inc.

No Recall History

Plain English

Itch Relief is a liquid containing diphenhydramine hydrochloride at 20.3 g/L, taken topical. Manufactured by Safetec of America, Inc..

Key Facts

Brand Name: Itch Relief
Generic Name: diphenhydramine hydrochloride
NDC Code (Product): 61010-8300
Manufacturer: Safetec of America, Inc.
Strength: 20.3 g/L
Dosage Form: LIQUID
Route: TOPICAL
Marketing Status
Application #: M017
Marketing Start: 05/02/2013

Recall History

No Recall History

Side Effects Reported to FDA

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

off label use15,517 reports

drug ineffective15,331 reports

fatigue12,697 reports

nausea11,331 reports

pain10,990 reports

headache10,523 reports

dyspnoea9,111 reports

diarrhoea8,773 reports

arthralgia8,568 reports

rash8,244 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 diphenhydramine hydrochloride. It is a liquid 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 diphenhydramine hydrochloride. There are 12 other brand versions of diphenhydramine hydrochloride.

What is the NDC code for Itch Relief 20.3 g/L?

The NDC (National Drug Code) for Itch Relief 20.3 g/L is 61010-8300, listed by Safetec of America, Inc..

Product NDC

61010-8300

Package NDC

61010-8300-1

Other Diphenhydramine Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)