Spa Soap Ultra 2X Liquld Soap

Antibacterial by

Drug Labeling and Warnings

Antibacterial by is a Otc medication manufactured, distributed, or labeled by Total Body Care Inc, Sante Manufcaturing Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL  UTRA 2X- benzalkonium chloride liquid 
Total Body Care 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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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: 54369-007
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 LAURETH SULFATE (UNII: BPV390UAP0)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54369-007-50	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/23/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/23/2020	12/31/2021

Labeler - Total Body Care Inc (250919615)

Registrant - Sante Manufcaturing Inc (242048747)

Revised: 1/2022

Document Id: d681d906-77f1-9bb8-e053-2a95a90af093

34390-5

Set id: b00026ba-55ed-f298-e053-2995a90a3937

Version: 3

Effective Time: 20220126