ANTIBACTERIAL AQUA CLEAR 2X ULTRA- benzalkonium chloride liquid

Antibacterial Aqua Clear by

Drug Labeling and Warnings

Antibacterial Aqua Clear by is a Otc medication manufactured, distributed, or labeled by Sante Manufacturing Inc, Brands International Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride - 0.13%

PURPOSE

Purpose: Antibacterial

DOSAGE & ADMINISTRATION

Direction

• wet hands
• apply palmful to hands
• scrub thoroughly
• rinse

WARNINGS

For external use only

STOP USE

Stop use and ask a doctor if irritation or redness develops

WHEN USING

When using this product

• do not get it into eyes. If contact occurs, rinse eye thoroughly with water

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

INACTIVE INGREDIENT

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1, Red# 4 (Cl 14700)

INDICATIONS & USAGE

Uses for handwashing or decrease bacteria to the skin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL AQUA CLEAR  2X ULTRA
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71020-030
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71020-030-64	1900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/08/2016
2	NDC: 71020-030-30	600 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/08/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/08/2016

Labeler - Sante Manufacturing Inc (242048747)

Registrant - Sante Manufacturing Inc (242048747)

Establishment
Name	Address	ID/FEI	Business Operations
Sante Manufacturing Inc		204348627	manufacture(71020-030)

Establishment
Name	Address	ID/FEI	Business Operations
Brands International Corporation		243748238	manufacture(71020-030)