Active Ingredient(S)
Ethyl Alcohol 70% v/v
Planeaire Hands Gel
FDA Label NDC 80335-112
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 Planeaire Hands (NDC 80335-112). 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,
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 on hands. Flammable. Keep away from heat and flame
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, rinse eyes thoroughly with water.
Stop use if irritation or rash 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.
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 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
Other Information
- Store between 15-30C (59-86F)
- do not store above 105F
- avoid freezing
- may discolor some fabrics
- may be harmful to some wood finishes and plastics
Inactive Ingredients
aloe vera inner leaf, carbomer, glycerin, green tea extract, mint oil fragrance blend , sodium hydroxide, water
Package Label - Principal Display Panel
Pah Label 80335-112-02 (Planeaire Hands Cool Mint Label Rev Nov 23 2020)
* Please review the disclaimer below.
