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.
- Sodium hydroxide
- 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 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, 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 if irritation or redness develops. 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 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
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 inner leaf, green tea extract, glycerin, Carbomer, lavender oil, lemon oil, oregano oil, peppermint oil, rosemary oil, thyme oil, water
Package Label - Principal Display Panel
60 mL NDC: 80335-105-02
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