Purpose
Antiseptic
Planeaire Hands Lotion
FDA Label NDC 80335-116
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 80335-116). 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 purpose, otc - active ingredient, indications & usage, warnings, do not use, discontinue use if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Ethyl alcohol 70 % v/v
Indications & Usage
- helps 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 wounds or near eyes. In case of contact with eyes, rinse thoroughly with watwer.
Discontinue Use If
- irritation or redness develops
- If cindiction 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.
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
- store between 15-30 C (59-86 F)
- do not store above 105 F
- avoid freezing
- may discolor some fabrics
- may be harmful to some wood finishes and plastics
- store between 15-30 C
- do not store above 105 F
- avoid freezing
- may discolor some fabrics
- may be harmful to some wood finishes and plastics
Dosage And Administration
Section name changed and sequence changed
Inactive Ingredients
Aloe Vera (Inner Leaf), Chlorella Vulgaris Powder, Glycerin, Green Tea Extract ( Camellia Sinensis Leaf), Lemongrass (Cymbopogon Schoenanthus) Oil, Lingonberry ( Vaccinium Vitis-Idaea) Seed Oil, Polyacrylate Crosspolymer-6, Rosemary (Rosmarinus Officinalis) Leaf Oil, Safflower Seed Oil ( Carthamus Tinctorius), Spirulina Platensis Powder, Water (Aqua)
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