ANTIBACTERIAL HAND- benzalkonium chloride liquid

ANTIBACTERIAL Hand by

Drug Labeling and Warnings

ANTIBACTERIAL Hand by is a Otc medication manufactured, distributed, or labeled by CROSS BORDER MANUFACTURERS INC., Absara Cosmetics SAPI de CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78939-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78939-001-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	09/16/2020

Labeler - CROSS BORDER MANUFACTURERS INC. (117543128)

Establishment
Name	Address	ID/FEI	Business Operations
Absara Cosmetics SAPI de CV		816161236	MANUFACTURE(78939-001)