The following Structured Product Label (SPL) was submitted to the FDA by Everywhereaire Llc for the product Planeaire Hands Hand Sanitizer (NDC 80335-113). 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 other, active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
The hand sanitizer is manufactured using only the following ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
Alcohol 70% v/v.
Antiseptic,
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
For external use only.- on hands. Flammable. Keep away from heat or flame
When using this product keep out of eyes, and open wounds. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use if irritation or redness occurs. If condition persists for more than 72 hours, consult a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a local Poison Control Center right away.
Stop use if irritation or redness occurs. If condition persists for more than 72 hours, consult a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Wet hands thoroughly with product, rub hands, and allow to dry without wiping
For children under 6 years of age, use only under adult supervision to avoid swallowing
not recommended for infants
Wet hands thoroughly with product, rub hands, and allow to dry without wiping
For children under 6 years of age, use only under adult supervision to avoid swallowing
not recommended for infants
aloe vera inner leaf, green tea extract, lemongrass oil blend, rosemary oil, carbomer, glycerin, sodium hydroxide, water
Pah Label 80335-107-02 (Planeaire Hands Lemongrass Rosemary Label Rev Nov 12 2020)
* Please review the disclaimer below.
