ITCH X- benzyl alcohol/pramoxine hydrochloride gel

ITCH X by

Drug Labeling and Warnings

ITCH X by is a Otc medication manufactured, distributed, or labeled by BF ASCHER AND CO INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

Benzyl alcohol 10%......................................Topical analgesic
Pramoxine hydrochloride 1%.......................Topical analgesic

PURPOSE

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

INDICATIONS & 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

WARNINGS

Warnings

• For external use only.
• Avoid contact with eyes.

DO NOT USE

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.

ASK DOCTOR

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.

STOP USE

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & 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

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

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

QUESTIONS

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - BF ASCHER AND CO INC (003854403)