Otc - Active Ingredient
Diphenhydramine HCl 2%, Zinc Acetate 0.1%
Goodsense Anti-itch Spray
FDA Label NDC 50804-064
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geiss, Destin & Dunn, Inc for the product Goodsense Anti-itch (NDC 50804-064). 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, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic, Skin Protectant
Indications & Usage
For the temporary relief of pain and itching associated with rashes due to poison ivy, oak and sumac, insect bites, minor skin irritations, minor cuts, dries the oozing and weeping of poison ivy, oak and sumac.
Warnings
Flammable. Keep away from excessive heat or open flame.
For external use only.
Do not use on chicken pox, on large areas of the body, with any other products containing diphenhydramine, even one take by mouth.
When using this product avoid spraying in eyes.
Stop use and ask a doctor if the condition worsens, rash or irritation develops and lasts for more than 7 days or clears up and occurs again within a few days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Adults and children 2 years or older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.
Inactive Ingredient
Blue 1, carbomer, isopropyl alcohol, magnesium sulfate, sodium hydroxide, water, and yellow 5.
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