ITCH-X- pramoxine hcl/benzyl alcohol spray

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
(in solution)
Benzyl alcohol 10%............Topical analgesic
Pramoxine HCl 1%..............Topical analgesic

INDICATIONS & USAGE

Uses temporarily relieves pain and itching associ- ated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, hives and rashes due to poison ivy, poison oak, or poison sumac.

PURPOSE

Uses temporarily relieves pain and itching associ- ated 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.
Keep away from fire or flame.

ASK DOCTOR

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a physician.

DO NOT USE

Do not apply to open wounds, damaged, or blistered skin.

Do not use for vaginal, genital, or rectal itching.

Do not use on children under 2 years of age unless under the advice and supervision of a physician.

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 overdose or ingestion of contents, 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)
• mfd. in the USA for B.F. Ascher & Co., Inc.

INACTIVE INGREDIENT

Inactive ingredients aloe barbadensis (aloe vera gel), SD alcohol 40, and water

QUESTIONS

Questions?

1-800-324-1880, 7:30am - 4:00pm Central, Mon. - Fri., or visit www.bfascher.com

PRINCIPAL DISPLAY PANEL

Itch-X Spray PDP

INGREDIENTS AND APPEARANCE

ITCH-X 
pramoxine hcl/benzyl alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0225-0516
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE (UNII: V5VD430YW9)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0225-0516-51	59.1 mL in 1 BOTTLE, SPRAY; 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)