Otc - Purpose
Acne treatment
Zapzyt Acne Treatment Gel
FDA Label NDC 71687-0011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Focus Consumer Healthcare, Llc for the product Zapzyt Acne Treatment Gel (NDC 71687-0011). 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 - purpose, otc - active ingredient, uses, warnings, directions, inactive ingredients, otc - keep out of reach of children, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Benzoyl Peroxide 10%
Uses
for the treatment and prevention of acne pimples, blemishes, blackheads or whiteheads
Warnings
For external use only.
DO NOT USE this product if you have sensitive skin or if you are sensitive to benzoyl peroxide
When using this product
Avoid unnecessary sun exposure and use sunscreen. Allow ZAPZYT acne gel to dry, then follow the sunscreen directions.
Avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product.
Skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Mild irritation may be reduced by using this product less frequently or in a lower concentration. If irritation becomes severe, discontinue use; if irritation still occurs consult a doctor.
Using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
Keep away from eyes, lips and mouth
Directions
Use a ZAPZYT cleaning product to thoroughly wash face before applying gel.
Apply ZAPZYT Acne Treatment Gel to areas where pimples and excess oil occur
Apply ZAPZYT before using moisturizer or makeup; do not rinse.
If excessive drying of the skin occurs, reduce applications to once a day, or every other day.
For best results use up to three tiimes daily. Once your skin has cleared, continue using ZAPZYT to keep new pimples from forming
Inactive Ingredients
Laureth-4, Carbomer 940, EDTA, Dilsopropanolamine, Purified Water USP
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away. Store at room temperature 15-30 degrees C (59-86 degrees F).
Principal Display Panel
Acne Treatment (Zapzytacnetreamtmentgel Secondarycarton)
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