Label: ABOVE HAND SANI ANTISEPTIC- benzalkonium chloride aerosol, foam
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Contains inactivated NDC Code(s)
NDC Code(s): 73306-6001-1 - Packager: Baston Industria De Aerossols Ltda
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 19, 2020
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Uses
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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.
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
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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).
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- Package Labeling:
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INGREDIENTS AND APPEARANCE
ABOVE HAND SANI ANTISEPTIC
benzalkonium chloride aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73306-6001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) BUTANE (UNII: 6LV4FOR43R) PROPANE (UNII: T75W9911L6) GLYCERIN (UNII: PDC6A3C0OX) ISOBUTANE (UNII: BXR49TP611) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) IMIDUREA (UNII: M629807ATL) SODIUM BENZOATE (UNII: OJ245FE5EU) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CHLORIDE (UNII: 451W47IQ8X) TEA TREE OIL (UNII: VIF565UC2G) SODIUM CITRATE (UNII: 1Q73Q2JULR) BENZOIC ACID (UNII: 8SKN0B0MIM) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BENZYL BENZOATE (UNII: N863NB338G) CITRAL (UNII: T7EU0O9VPP) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) GERANIOL (UNII: L837108USY) LIMONENE, (+)- (UNII: GFD7C86Q1W) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73306-6001-1 130 g in 1 CAN; Type 0: Not a Combination Product 08/14/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 08/14/2020 Labeler - Baston Industria De Aerossols Ltda (897727605)