Active Ingredient(S)
Benzalkonium Chloride 0.13%
hydrogen Peroxide.1%
Reearth Hand Sanitizer
FDA Label NDC 77368-021
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nugentec for the product Reearth Hand Sanitizer (NDC 77368-021). 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, 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, Antibacterial
Use
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. Avoid Contact with Eyes.
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 of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Wet hands thoroughly with the product to cover all surfaces. Allow to dry without wiping.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
- Store between 0-40C (32-104F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
glycerin, purified water USP, Aloe, Fragrance, Sodium Citrate, Phenoxyethanol, Polysorbate 20
Package Label - Principal Display Panel
Reearthlabel Front And Back (Reearth Liquid Mockup 20201013 Rev2)
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