SPASOAP ANTIBACTERIAL- benzalkonium chloride liquid

SpaSoap by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride - 0.13%

PURPOSE

Purpose - Antibacterial

INDICATIONS & USAGE

Uses for handwashing or decrease bacteria to the skin

WARNINGS

For external use only

STOP USE

Stop use and ask a doctor if irritation or redness develops

WHEN USING

When using the product

• do not get 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

DOSAGE & ADMINISTRATION

Directions

• Wet Hands
• Apply palmful to hands
• Scrub thoroughly
• Rinse

INACTIVE INGREDIENT

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow# 5 (Cl 19140), Red# 4 (Cl14700)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPASOAP  ANTIBACTERIAL
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54369-005
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
GLYCERIN (UNII: PDC6A3C0OX)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
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: 54369-005-16	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/05/2020
2	NDC: 54369-005-60	600 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/05/2020
3	NDC: 54369-005-32	947 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/05/2020

Labeler - Total Body Care Inc (250919615)