PERSONAL CARE ANTIBACTERIAL DEODORANT- benzalkonium chloride soap
Delta Brands & Products, LLC

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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Antibacterial Soap

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

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 develops

Keep out of reach of children

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

Directions

■ wet bar with water ■ lather vigorously and wash skin ■ rinse and dry thoroughly

Inactive ingredients

sodium palm kernelate, sodium palmate, water, fragrance, glycerin, sodium chloride, tetrasodium EDTA, FD&C yellow no. 5, FD&C red no. 4

Package Label

PERSONAL CARE ANTIBACTERIAL DEODORANT
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72133-049
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
SODIUM PALMITATE (UNII: JQ43KP6296)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE SODIUM (UNII: MP1J8420LU)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72133-049-06	170 g in 1 BOX; Type 0: Not a Combination Product	09/21/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/21/2018

Labeler - Delta Brands & Products, LLC (080999173)