Active Ingredient(S)
Ethyl Alcohol 70% v/v. Purpose: Antiseptic
Hand Sanitizer Gel
FDA Label NDC 80335-114
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 Hand Sanitizer Gel (NDC 80335-114). 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
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 or flame
Do Not Use
- on open wounds or near eyes. In case of contact with eyes, rinse thoroughly with water.
Otc - When Using
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, cnsukt 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 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 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
Helps Reduce Bacteria That Potentially Can Cause Disease. For Use When Soap And Water Are Not Available.
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 tio some wood finishes and plastics
Inactive Ingredients
Aloe Vera (Inner leaf)
Basil (Ocimum Basilicum) Leaf Extract
Chlorella Vulgaris Powder
Glycerin
Green tea (Camellia Sinensis) Leaf Extract
Lingonberry (Vaccinium Vitis-Idaea) Seed Oil
Polyacrylate Crosspolymer-6
Pomegranate (Punica Granatum) seed oil
Pomegranate fragrance
Safflower (Carthamus Tinctorius ) seed oil
Spirulina Platensis Powder
Water
Package Label - Principal Display Panel Ndc 80335-114-02
NDC: 80335-114Pomegranate Basil hand sanitizer gel 80335-114-02
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