Revitalize Sports Hand Sanitizer
FDA Label NDC 81250-080
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Revive Sports Inc. for the product Revitalize Sports Hand Sanitizer (NDC 81250-080). 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 drug facts, active ingredient:, purpose, use(s):, warning:, otc - keep out of reach of children, directions:, ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient:
Ethyl Alcohol 62%
Purpose
Antiseptic
Use(S):
Hand Sanitizer to help reduce bacteria that potentially can cause disease For use when soap and water are not available.
Warning:
For external use only. Flammable, Keep from heat and flame.
Do not use • on infants • 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.
Stop use and ask a doctor if irritation or rash occurs. These maybe signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
Apply as needed into the palm of hand and thoroughly spread on both hands, rub until dry. Supervise children under 6 years of age when using product.
Ingredients
Water, Glycerin, Carbomer 980, Triethanolamine
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Packaging
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