Other
This is a hand sanitizer
Planeairehands Hand Sanitizer
FDA Label NDC 80335-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Everywhereaire Llc for the product Planeairehands Hand Sanitizer (NDC 80335-104). 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.
Label Section Quick Index
Active Ingredient(S)
Ethyl Alcohol 70% v/v.
Purpose
Antiseptic
Use
Helps reduce bacteria that potentially may cause disease. For use when soap and water are not avaiable.
Warnings
For external use only.- hands. Flammable. Keep away from heat or flame
Do Not Use
- do not use on open skin wounds or near eyes. In case of contact with eyes, rinse thoroughly with water
Otc - When Using
When using this product keep out of eyes. In case of contact with eyes, fllush eyes thoroughly with water.
(
See Stop use section: Stop use and ask a doctor if irritation or rash lasts for longer than 72 hours )
.
Keep out of reach of children. If swallowed, get medical help or contact a local Poison Control Center right away.
Otc - Stop Use
Discontinue use if irritation or rash occurs. If condition persists for more than 72 hours, consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
Directions
- 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
Other Information
- Do not store above 105F
- May discolor some fabrics
- Harmful to wood finishes and plastics
Inactive Ingredients
aloe vera inner leaf, green tea extract, carbomer 980, lemon oil, lavender oil, peppermint oil, oregano oil, rosemary oil, thyme oil, sodium hydroxide, water
Indications And Usage Helps Reduce Bacteria That Potentially Cause Disease. For Use When Soap And Water Are Not Available Directions 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
Indications and Usage
To decrease bacteria on skin that could cause diease. Recommended for repeated use.
Dosage and Administration
Wet hands thoroughly with product and allow to dry without wiping
For children under 6, use only under adult supervision
Not recommended for infants
Package Label - Principal Display Panel
Pah Label 80335-104-02 (Planeaire Hands Signature Herbal Label Rev Nov 12 2020)
* Please review the disclaimer below.
