FDA Label for Natural
View Indications, Usage & Precautions
Natural Product Label
The following document was submitted to the FDA by the labeler of this product International General Trading Corp. 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
Purpose
Antibacterial
Use
FOR HANDWASHING TO DECREASE BATERIA ON THE SKIN
Warnings
For external use only.
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
When using this product do not get into yes. If contact occurs rinse eye throughly with water
Otc - Stop Use
stop use and ask a docor if irritation or 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
Wash hands, apply palful to hhand rub thoughly and rinse
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
WATER, SODIUM LAURYLETHER SULFATHEM COCOAMIDO PROPYL, BETAINE, GLYCERIN, ESSENTIAL OILS, SODIUM CHORIDE, COLLAGEN. SODIUMFEINT, SALT, ALOE VERA, YELLOW#5 d&c, RED#4 D&C
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