Spa Soap Ultra 2X Liquld Soap

Antibacterial by

Drug Labeling and Warnings

Antibacterial by is a Otc medication manufactured, distributed, or labeled by The Right Solutions Corporation, Sante Manufcaturing Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL UTRA 2X- benzalkonium chloride liquid 
The Right Solutions Corporation

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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Spa Soap Ultra 2X Liquld Soap

Benzalkonium Chloride - 0.13%

Purpose - Antibacterial

Uses for handwashing or decrease bacteria to the skin

Warning For external use only

Stop use and ask a doctor if irritation or redness develops

When using the product

• Do not get into eyes. If contact occurs rinse eye thoroughly with water

Keep out of reach of children

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

Direction

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

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow #5 (Cl 19140), Red #4 (Cl 14700)

ANTIBACTERIAL  UTRA 2X
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64855-006
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
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64855-006-50	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/23/2020	08/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/23/2020	08/15/2022

Labeler - The Right Solutions Corporation (203855150)

Establishment
Name	Address	ID/FEI	Business Operations
The Right Solutions Corporation		203855150	manufacture(64855-006)

Revised: 5/2022

Document Id: 3d6cc4f1-a7ec-4f1e-9909-db72ef7718c2

34390-5

Set id: b07617f5-59de-107a-e053-2a95a90a1cb7

Version: 2

Effective Time: 20220518