FDA Label for Sombra Antibacterial Hand Sanitizer

View Indications, Usage & Precautions

Sombra Antibacterial Hand Sanitizer Product Label

The following document was submitted to the FDA by the labeler of this product Sombra Cosmetics. 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.

Active Ingredients



Ethyl Alcohol 65% v/v


Uses



To decrease bacteria and viruses on the skin that could cause disease.  Recommended for repeated use.


Warnings



For external use only: hands.  Flammable, keep away from fire or flame.


Do Not Use



avoid contact with broken skin. Do not inhale or ingest.  Children under 6, use only
under adult supervision.  Not recommended for infants.


When Using



When using this product, keep out of the eyes. In case of contact with eyes, flush thoroughly with water.


Otc - Stop Use



Stop use if irritation and redness develop or if condition persists for more than 72 hours.


Otc - 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.


Storage And Handling



Do not store above 105 F.  May discolor some fabrics and may harm wood finishes.


Inactive Ingredients



glycerin, purified water, isopropyl alcohol, aminomethyl propanol, citrus limon (lemon) peel oil, citrus aurantium dulcis (orange) peel oil, yucca schidigera stem extract,  rosa damascena flower water, hamamelis virginiana (witch hazel) leaf extract, filipendula ulmaria (queen of the prairie) extract, camellia sinensis (green tea) leaf extract, aloe barbadensis leaf extract.


Purpose



Antiseptic


Package Label.Principal Display Panel




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