Otc - Active Ingredient
Active ingredients
Chloroxylenol 0.52%
Instant Hand Sanitizer
FDA Label NDC 69556-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kentron Healthcare, Inc. for the product Instant Hand Sanitizer (NDC 69556-002). 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, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiseptic
Warnings
Warnings: For external use only.
Do not apply around eyes.
Do not use in ears or mouth.
When using this products, avoid contact with eyes. In case of contact, flush eyes with water.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Children must be supervised in use of this product.
Dosage & Administration
Directions:
Pump as needed into your palms and thoroughly spread on both hands.
Rub into skin until dry.
Inactive Ingredient
Inactive Ingredients:Water, Cetearyl Alcohol, Mineral Oil, Petrolatum, Stearic Acid, DMDM Hydantoin, Ceteareth-20, Triethanolamine, Carbomer, Methyl Pareben, Propyl Paraben, Fragrance, Disodium EDTA, Aloe Barbadensis Leaf Juice
Indications & Usage
Uses: Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. Recommended for repeated use.
Storage And Handling
Other information: Do not store in temperature above 118 F.
Otc - Stop Use
Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.
Package Label.Principal Display Panel
Image Of Bottle Label (Hks)
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