FDA Label for Novapur Creamy Moisturizing Hand Sanitizer
View Indications, Usage & Precautions
Novapur Creamy Moisturizing Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Les Entreprises Stefmar Inc. 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
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.
Active Ingredient(S)
Benzalkonium Chloride 0.15% w/w
Purpose
Antimicrobial
Use
For hand-washing to decrease bacteria on the skin, only when water is not available. For occasional personal domestic use.
Warnings
For external use only.
Do Not Use
- in children less than 2 years old
- on open wounds
Otc - When Using
When using this product
- do not get into eyes.
- if contact occurs, rinse thoroughly with water.
.
Otc - Stop Use
Stop use and ask a doctor if
irritation and redness develops.
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
Directions
- Supervise children when they use this product
- Rub thoroughly into hands for at least 30 seconds and allow to dry
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
Aqua, Caprylic/Capric Triglyceride, Propylene glycol, Phenoxyethanol, Sodium polyacrylate, Ethylhexylglycerin, Aloe barbadensis leaf juice, Tocopherol
Package Label - Principal Display Panel
500 mL NDC: 71316-100-50
150 mL NDC: 71316-100-15
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