Active Ingredient
Benzalkonium Chloride 0.15%(w/w)
Foam 103
FDA Label NDC 75009-103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Alpha Aromatics for the product Foam 103 (NDC 75009-103). 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, use, warnings, otc - stop use, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anitbacterial
Use
Handwash to help decrease bacteria on the skin
Warnings
For external use only. Avoid contact with eyes. If eye contact occurs, flush eyes with water.
Stop use if, in rare instances, redness or irritation develops. If condition persists for more than 72 hours, consult a physician.
Otc - Stop Use
Stop use if, in rare instances, redness or irrtiation develops. If condition persists for more than 72 hours, consult a physician.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, contact a physician or poison control center.
Directions
To decrease bacteria on the skin, apply a small amount, covering hands with product for 30 seconds. Add water, lather, and rinse.
Inactive Ingredients
water, sorbitol, glycerine, decyl glucoside, dmdm hydantoin, fragrance.
Package Label - Principal Display Panel
3.78 L NDC: 75009-103-01
18.92 L NDC: 75009-103-02
208.19 L NDC: 75009-103-03
1040.98 L NDC: 75009-103-04
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