FDA Label for Above Hand Sani Antiseptic

View Indications, Usage & Precautions

Above Hand Sani Antiseptic Product Label

The following document was submitted to the FDA by the labeler of this product Baston Industria De Aerossols Ltda. 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 Ingredient



Benzalkonium Chloride (0,10%)


Purpose



antiseptic


Uses



Hand sanitizer to help decrease bacteria on the skin. Recommended for repeated use


Warnings



FLAMMABLE. DO NOT USE NEAR HEAT, FLAME OR WHILE SMOKING. CAN CAUSE SERIOUS INJURY OR DEATH

  • KEEP AWAY FROM FACE AND MOUTH TO AVOID CONTACT 

Do Not Use



IN OR NEAR THE EYES. IN CASE OF CONTACT WITH EYES, RINSE THOROUGHLY WITH WATER. CONTENTS UNDER PRESSURE. DO NOT
PUNCTURE OR INCINERATE. DO NOT EXPOSE TO HEAT, SUNLIGHT OR STORE AT TEMPERATURES ABOVE 120°F/50°C OR IN ENCLOSED PLACES THAT COULD OVERHEAT

  • DO NOT USE ON BROKEN SKIN.

Stop Use If



RASH OR IRRITATION OCCURS. GET MEDICAL ATTENTION IMMEDIATELY


Keep Out Of Reach Of Children



AND ANIMALS USE ONLY AS DIRECTED. FOR EXTERNAL USE ONLY. IF SWALLOWED, DO NOT INDUCE VOMITING. CONSULT YOUR HEALTHCARE PROVIDER IMMEDIATELY DO NOT LEAVE THE AEROSOL CONTAINER IN A VEHICLE. RISK OF LEAKAGE AND EXPLOSION. CONTAINER MATERIAL: ALUMINUM BATCH AND EXPIRATION ON THE BOTTOM OF THE CONTAINER.


Directions



Shake well before using. Put a small amount in your palm and rub hands together briskly until dry, always holding the container in an upright position. No rinsing required. No towels needed. 


Inactive Ingredients



AQUA / ALCOHOL / BUTANE / PROPANE / GLYCERIN / ISOBUTANE / COCAMIDOPROPYL BETAINE / TOCOPHERYL ACETATE / PEG-12 DIMETHICONE / IMIDAZOLIDINYL UREA / SODIUM BENZOATE / PROPYLENE GLYCOL / ALOE BARBADENSIS EXTRACT / SODIUM CHLORIDE / MELALEUCA ALTERNIFOLIA LEAF OIL / EUGENIA CARYOPHYLLUS LEAF OIL / SODIUM CITRATE / BENZOIC ACID / CITRIC ACID / PARFUM (BENZYL BENZOATE / CITRAL / CITRONELLOL /GERANIOL / LIMONENE / HEXYL CINNAMAL / LINALOOL).


Questions?



e-mail [email protected] or call: +1 (305) 677-5030


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