ITCH X- benzyl alcohol/pramoxine hydrochloride gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH), PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)

Available from:

BF ASCHER AND CO INC

INN (International Name):

BENZYL ALCOHOL

Composition:

BENZYL ALCOHOL 10 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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 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 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. 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.

Authorization status:

OTC monograph not final

Summary of Product characteristics

ITCH X- BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE GEL
BF ASCHER AND CO INC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
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ITCH-X GEL
ACTIVE INGREDIENTS......................................PURPOSE
Benzyl alcohol 10%......................................Topical
analgesic
Pramoxine hydrochloride 1%.......................Topical analgesic
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
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
For external use only.
Avoid contact with eyes.
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.
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 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.
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP THIS AND ALL DRUGS out of reach of children. In case of
ingestion, get medical help
or contact a poison control center immediately.
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
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 INGREDIENTS: aloe barbadensis leaf juice (aloe vera gel),
blue 1, butylene glycol,
carbomer, citric acid, diazolidinyl urea, iodopropy