Itch-x Gel

Itch-x Gel
SPL v6
SPL
SPL Set ID 03c16d33-8f59-0184-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2014-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzyl Alcohol (10 g) Pramoxine (1 g)
Inactive Ingredients
Butylene Glycol Alcohol Aloe Water Edetol Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Diazolidinyl Urea Fd&c Blue No. 1 Sodium Benzoate Sulfite Ion Potassium Sorbate Iodopropynyl Butylcarbamate Citric Acid Monohydrate Styrene/ammonium Acrylate Copolymer (300000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-09-19
Description

Active ingredients......................................Purpose Benzyl alcohol 10%......................................Topical analgesic Pramoxine hydrochloride 1%.......................Topical analgesic

Medication Information

Warnings and Precautions

Warnings

  • For external use only.
  • Avoid contact with eyes.
Indications and Usage

Use

Temporarily relieves pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, hives and rashes due to poison ivy, poison oak, or poison sumac

Dosage and Administration

Directions

  • adults and children 2 years and older - apply to affected area not more than 3 or 4 times daily
  • children under 2 years - consult a physician
Description

Active ingredients......................................Purpose Benzyl alcohol 10%......................................Topical analgesic Pramoxine hydrochloride 1%.......................Topical analgesic

Section 44425-7

Other information

  • store at 59°-86° F (15°-30° C) in a dry place
  • mfd. in the USA for B.F. Ascher & Co., Inc.
Section 50565-1

Keep this and all drugs out of reach of children. In case of ingestion, get medical help or contact a poison control center immediately.

Section 50566-9

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50569-3

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50570-1

Do not use

  • on open wounds, damaged, or blistered skin.
  • for vaginal, genital, or rectal itching.
  • on children under 2 years of age unless under the advice and supervision of a physician.
Section 51727-6

Inactive ingredients: aloe barbadensis leaf juice (aloe vera gel), blue 1, butylene glycol, carbomer, citric acid, diazolidinyl urea, iodopropynyl butylcarbamate, potassium sorbate, SD alcohol 40, sodium benzoate, sodium sulfite, styrene/acrylates copolymer, tetrahydroxypropyl ethylenediamine, and water

Section 51945-4

Itch-X Gel PDP

Section 53413-1

Questions? Call 1-800-324-1880, 7:30am - 4:00pm Central, M - F, or visit bfascher.com

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Use

Temporarily relieves pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, hives and rashes due to poison ivy, poison oak, or poison sumac

Section 55106-9

Active ingredients......................................Purpose

Benzyl alcohol 10%......................................Topical analgesic

Pramoxine hydrochloride 1%.......................Topical analgesic

Structured Label Content

Indications and Usage (34067-9)

Use

Temporarily relieves pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, hives and rashes due to poison ivy, poison oak, or poison sumac

Dosage and Administration (34068-7)

Directions

  • adults and children 2 years and older - apply to affected area not more than 3 or 4 times daily
  • children under 2 years - consult a physician
Warnings and Precautions (34071-1)

Warnings

  • For external use only.
  • Avoid contact with eyes.
Section 44425-7 (44425-7)

Other information

  • store at 59°-86° F (15°-30° C) in a dry place
  • mfd. in the USA for B.F. Ascher & Co., Inc.
Section 50565-1 (50565-1)

Keep this and all drugs out of reach of children. In case of ingestion, get medical help or contact a poison control center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50569-3 (50569-3)

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50570-1 (50570-1)

Do not use

  • on open wounds, damaged, or blistered skin.
  • for vaginal, genital, or rectal itching.
  • on children under 2 years of age unless under the advice and supervision of a physician.
Section 51727-6 (51727-6)

Inactive ingredients: aloe barbadensis leaf juice (aloe vera gel), blue 1, butylene glycol, carbomer, citric acid, diazolidinyl urea, iodopropynyl butylcarbamate, potassium sorbate, SD alcohol 40, sodium benzoate, sodium sulfite, styrene/acrylates copolymer, tetrahydroxypropyl ethylenediamine, and water

Section 51945-4 (51945-4)

Itch-X Gel PDP

Section 53413-1 (53413-1)

Questions? Call 1-800-324-1880, 7:30am - 4:00pm Central, M - F, or visit bfascher.com

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Use

Temporarily relieves pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, hives and rashes due to poison ivy, poison oak, or poison sumac

Section 55106-9 (55106-9)

Active ingredients......................................Purpose

Benzyl alcohol 10%......................................Topical analgesic

Pramoxine hydrochloride 1%.......................Topical analgesic

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:37.710959 · Updated: 2026-03-14T23:05:30.485285