Uses
Products 17 & 78: For handwashing to decrease bacteria on skin.
Product 41: Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.
Rx200 Foaming Instant Hand Sanitizer
FDA Label NDC 57356-207
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Bullen Companies, Inc. for the product Rx200 Foaming Instant Hand Sanitizer (NDC 57356-207). 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 uses, purpose, active ingredient, warnings, inactive ingredients, directions, 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
Purpose
Products 17 & 78: Antibacterial Agent
Product 41: Antibacterial Handwashing
Active Ingredient
Benzalkonium Chloride 0.13% w/w
Warnings
Products 17 & 41: For external use only.Avoid contact with eyes. If contact occurs, flush with water. Stop use and ask a doctor if, in rare instances, redness or irritations develops. If condition persists for more than 72 hours, consult a physician. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.
Product 78: For external use only.Do not use in the eyes. In rare instances of redness or irritation, discontinue use. If condition persists for more than 72 hours, consult a physician. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.
Inactive Ingredients
Water, Propylene Glycol, Cocamidopropyl Betaine, Aloe Barbadensis Leaf, Tocopheryl Acetate (Vitamin E), PEG-7 Glyceryl Cocoate, Fragrance, Phenoxyethanol, Tetrasodium EDTA.
Directions
To decrease bacteria on skin, apply a small amount to palm. Briskly rub covering hands with product until dry.
Package Label.Principal Display Panel
20741bco Label (57356 207 41)
57356-207-17.jpg (57356 207 17)
20778bco Label (57356 207 78)
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