ABOVE HAND SANI ANTISEPTIC- benzalkonium chloride aerosol, foam 
Baston Industria De Aerossols Ltda

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.

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Above Hand Sani Antiseptic

Drug Facts

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

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 support@myspray.group or call: +1 (305) 677-5030

Package Labeling:

Label

ABOVE HAND SANI ANTISEPTIC 
benzalkonium chloride aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73306-6001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73306-6001-1130 g in 1 CAN; Type 0: Not a Combination Product08/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/14/2020
Labeler - Baston Industria De Aerossols Ltda (897727605)

Revised: 8/2020
Document Id: ad402dcb-e50e-4e00-e053-2a95a90a5ba6
Set id: ad4035c0-6792-7082-e053-2995a90a7d94
Version: 1
Effective Time: 20200819
 
Baston Industria De Aerossols Ltda