Active Ingredient
Diphenhydramine HCl 2%
Itch Eraser Gel
FDA Label NDC 44224-1116
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tender Corporation D/b/a Adventure Ready Brands for the product Itch Eraser Gel (NDC 44224-1116). 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 active ingredient, purpose, uses, warnings, do not use, ask a doctor before use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses
For temporrary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to posion ivy, poison oak, and poison sumac
Warnings
For external use only
Do Not Use
on large areas of the body, with any other product containing diphenhydramine, even one taken by mouth
Ask A Doctor Before Use
on chicken pox, on measles
When Using This Product
avoid contact with eyes
Stop Use And Ask A Doctor If
condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children
if swallowed, get medical help or contact poison control center right away
Directions
Do not use more often than directed, Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: consult a doctor
Inactive Ingredeints
aloe vera, citric acid, ethyl alcohol, glycerin, methocel, methylparaben, oat beat glucan, propylparaben, purified water, sodium hydroxide, tea tree oil, vitamin e
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