Otc - Active Ingredient
Active ingredients......................................Purpose
Benzyl alcohol 10%......................................Topical analgesic
Pramoxine hydrochloride 1%.......................Topical analgesic
Itch X Gel
FDA Label NDC 0225-0495
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bf Ascher And Co Inc for the product Itch X (NDC 0225-0495). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Use
For temporarily relief of 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.
Otc - 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
Warnings
Warnings
- For external use only.
- Avoid contact with eyes.
Otc - 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.
Otc - 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.
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 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, diazolidinyl urea, methylparaben, propylene glycol, propylparaben, SD alcohol 40, styrene/acrylates copolymer, tetrahydroxypropyl ethylenediamine, and water
Otc - Questions
Questions? Call 1-800-324-1880, 7:30am - 4:00pm Central, M - F, or visit www.bfascher.com
Package Label.Principal Display Panel
Itch-X Gel PDP
Itch-x Gel Pdp (Itch Xgel)
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