FDA Label for Planeaire Hands Hand Sanitizer
View Indications, Usage & Precautions
Planeaire Hands Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Everywhereaire Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol
- Sterile distilled water or boiled cold water
- Other inactive ingredients.
Active Ingredient(S)
Alcohol 70% v/v.
Purpose
Antiseptic, Hand Sanitizer
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 or flame
Do Not Use
- on open wounds or near eyes.
Otc - When Using
In case of contact with eyes, rinse eyes thoroughly with water.
Stop use if irritation or rash occurs. If conditon 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 if irritation or rash occurs. If conditon 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 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
Dosage And Administration 12/20
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, green tea extract, carbomer, glycerin, lemon oil, carrot seed oil, sodium hydroxide, water
Package Label - Principal Display Panel
60 mL NDC: 80335-106-02
* Please review the disclaimer below.