FDA Label for Itch-x
View Indications, Usage & Precautions
Itch-x Product Label
The following document was submitted to the FDA by the labeler of this product Bf Ascher And Co Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - 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.
Otc - 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.
Otc - 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.
Otc - 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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
Otc - Questions
Questions?
1-800-324-1880, 7:30am - 4:00pm Central, Mon. - Fri., or visit www.bfascher.com
Package Label.Principal Display Panel
Itch-X Spray PDP
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