ANTIBACTERIAL HAND- benzalkonium chloride liquid 
CROSS BORDER MANUFACTURERS INC.

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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ANTIBACTERIAL Hand Soap

DRUG FACTS

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

For washing to decrease bacteria on the skin.

Warnings

For external use only.

When using this product

  • Avoid contact with eyes.
  • In case of eye contact, flush with water.

Stop use and ask a doctor if

  • irritation and redness develop.

+ Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands with water, apply soap and rub for 20 seconds and rinse.

Inactive ingredients

Water, sodium laureth sulfate, cocamidopropyl betaine, sodium chloride, glycerin, polyquaternium -7, fragance, DMDM hydantoin, iodopropynyl butylcarbamate, butylene glycol, chamomilla recutita extract, aloe barbadensis extract, citral, limonene, citronellol, disodium EDTA, linalool, geraniol, hexyl cinnamal, citric acid, yellow 5 (CI 19140), red 40 (CI 16035), glycol distearate, cocamide MEA, Laureth-10

Questions?

Email: info@aglamee.com

Distributed by Cross-Border Manufacturers Inc.
Dover, DE, 19901

PRINCIPAL DISPLAY PANEL - 500 ML Bottle Label

aglameé

ANTIBACTERIAL
hand
soap

FRESH CITRUS
WITH CHAMOMILE +ALOE VERA

ANTIBACTERIAL
FORMULA

500 ML | 16.9 FL.OZ

PRINCIPAL DISPLAY PANEL - 500 ML Bottle Label
ANTIBACTERIAL HAND 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78939-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CITRAL (UNII: T7EU0O9VPP)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
GERANIOL (UNII: L837108USY)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
LAURETH-10 (UNII: BD7AST04GA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78939-001-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A09/16/2020
Labeler - CROSS BORDER MANUFACTURERS INC. (117543128)
Establishment
NameAddressID/FEIBusiness Operations
Absara Cosmetics SAPI de CV816161236MANUFACTURE(78939-001)

Revised: 9/2020
Document Id: 74bca929-389f-4da4-988e-c6d2d02233c8
Set id: f9ee3405-8dfb-4ffe-8e1b-495f8d1438a7
Version: 1
Effective Time: 20200922
 
CROSS BORDER MANUFACTURERS INC.