Active Ingredient(S)
Ethyl Alcohol 70%
100ml Gardenia Hand Purifying
FDA Label NDC 74819-0100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Bea for the product 100ml Gardenia Hand Purifying (NDC 74819-0100). 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), other, purpose, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Other
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
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) (80%, 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 (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
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. Flammable. Keep away from heat or flame. When using the product, keep out of eyes. Do not inhale or ingest.
Do Not Use
on open skin wounds - around eyes - in ears and mouth
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, flush thoroughly with water.
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 and allow to dry without wiping.
- Supervise children under 6 years of age when using this product to avoid swallowing.
- Not recommended for infants
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
- May discolor some fabrics
- Harmful to wood finishes and plastics
Inactive Ingredients
Aqua (Water), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Parfum (Fragrance), Triethanolamine, Aloe Barbadensis Leaf Juice Powder
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