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NDC 00225-0495-33 ITCH X 10; 1 g/100g; g/100g Details

ITCH X 10; 1 g/100g; g/100g

ITCH X is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by BF ASCHER AND CO INC. The primary component is BENZYL ALCOHOL; PRAMOXINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Benzyl alcohol lotion is used to treat head lice (small insects that attach themselves to the skin) in adults and children 6 months of age and older. It should not be used in children less than 6 months of age. Benzyl alcohol is in a class of medications called pediculicides. It works by killing the lice. Benzyl alcohol lotion will not kill lice eggs, so the medication must be used a second time to kill the lice that may hatch from these eggs.

Related Packages: 00225-0495-33
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Benzyl Alcohol Topical

Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.

Related Packages: 00225-0495-33
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pramoxine

Product Information

NDC	00225-0495
Product ID	0225-0495_ec8208ae-21d1-51d7-e053-2a95a90ad50d
Associated GPIs	90859902924020
GCN Sequence Number	014190
GCN Sequence Number Description	pramoxine HCl/benzyl alcohol GEL (GRAM) 1 %-10 % TOPICAL
HIC3	L3P
HIC3 Description	ANTIPRURITICS,TOPICAL
GCN	85140
HICL Sequence Number	005169
HICL Sequence Number Description	PRAMOXINE HCL/BENZYL ALCOHOL
Brand/Generic	Brand
Proprietary Name	ITCH X
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	10; 1
Active Ingredient Units	g/100g; g/100g
Substance Name	BENZYL ALCOHOL; PRAMOXINE HYDROCHLORIDE
Labeler Name	BF ASCHER AND CO INC
Pharmaceutical Class	Pediculicide [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00225-0495-33 (00225049533)

Pricing Information
NDC Package Code	0225-0495-33
Billing NDC	00225049533
Package	35.4 g in 1 TUBE (0225-0495-33)
Marketing Start Date	2014-09-19
NDC Exclude Flag	N
Price Per Unit	0.08157
Pricing Unit	GM
Effective Date	2022-04-20
NDC Description	ITCH-X GEL
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2022-11-23

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 03c16d33-8f59-0184-e054-00144ff8d46c Details

SPL UNCLASSIFIED SECTION

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

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

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Warnings

For external use only.
Avoid contact with eyes.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Other information

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

Itch-X Gel PDP

INGREDIENTS AND APPEARANCE

ITCH X

benzyl alcohol/pramoxine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0225-0495
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH)	BENZYL ALCOHOL	10 g in 100 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
ALOE (UNII: V5VD430YW9)
WATER (UNII: 059QF0KO0R)
EDETOL (UNII: Q4R969U9FR)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM SULFITE (UNII: VTK01UQK3G)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
STYRENE/AMMONIUM ACRYLATE COPOLYMER (300000 MW) (UNII: PA4J9TF5U2)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0225-0495-33	35.4 g in 1 TUBE; Type 0: Not a Combination Product	09/19/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/19/2014

Labeler - BF ASCHER AND CO INC (003854403)

Revised: 11/2022

Document Id: ec8208ae-21d1-51d7-e053-2a95a90ad50d

Set id: 03c16d33-8f59-0184-e054-00144ff8d46c

Version: 5

Effective Time: 20221102

Search by Drug Name or NDC

NDC 00225-0495-33 ITCH X 10; 1 g/100g; g/100g Details

ITCH X 10; 1 g/100g; g/100g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00225-0495-33 (00225049533)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 03c16d33-8f59-0184-e054-00144ff8d46c Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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