Otc - Keep Out Of Reach Of Children
Keep out of reach of children
0.13% Benzalkonium Chloride Instant Hand Sanitizer
FDA Label NDC 79635-019
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bj Goods Llc for the product 0.13% Benzalkonium Chloride Instant Hand Sanitizer (NDC 79635-019). 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 - keep out of reach of children, indications & usage, otc - purpose, dosage & administration, otc - active ingredient, warnings, 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
Indications & Usage
Directions: Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.
Indications & Usage Section (Directions)
Otc - Purpose
Use: Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Purpose (Use)
Dosage & Administration
Dosage form: Gel
Directions: Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.
Indications & Usage Section (Directions)
Otc - Active Ingredient
Benzalkonium Chloride 0.13% v/v
Warnings
Warnings: For external use only. Flammable. Keep away from heat or flame.
Warnings (Warnings)
Do not use: In children less than 2 months of age. On open skin wounds.
When using this product: Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Warnings_1 (Warnings 1)
Stop use and ask a doctor if: irritation or rash occurs. These may by signs o a serious condition.
Inactive Ingredient
Aloe, glycerin, sterile distilled water
Package Label.Principal Display Panel
Anti-Bacterial Hand Sanitizer (Disinfectant Gel) free - alcohol
3.8L label NDC: 79635-019-05
60 ml label NDC:79635-019-01
100 ml label NDC: 79635-019-02
240 ml label NDC: 79635-019-03
500 ml label NDC: 79635-019-04
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