Active Ingredient(S)
Alcohol 80% v/v. Purpose: Antiseptic
Gentle Hands Sanitizer Calming Citrus
FDA Label NDC 74299-281
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Southern Distilling Company Llc for the product Gentle Hands Sanitizer Calming Citrus (NDC 74299-281). 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(s), purpose, use(s), warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic, Hand Sanitizer
Use(S)
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame.
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out or reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
Glycerin, hydrogen peroxide, purified water USP, fragrance containing essential oil
Gentle Hands Sanitizer Spray Calming Citrus 2 Oz 59 Ml
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Gentle Hands Sanitizer Spray Calming Citrus 2 Oz 59 mL (Calmingcitrus 2oz(compressed))
Gentle Hands Sanitizer Spray Calming Citrus 3.4 Oz 100 Ml
.jpg "CalmingCitrus_3.4oz(compressed).jpg")
Gentle Hands Sanitizer Spray Calming Citrus 3.4 Oz 100 mL (Calmingcitrus 3.4oz(compressed))
Gentle Hands Sanitizer Spray Calming Citrus 32 Oz 946.35 Ml
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Gentle Hands Sanitizer Spray Calming Citrus 32 Oz 946.35 mL (Calmingcitrus 32oz(compressed))
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