ANTIBACTERIAL HAND- benzalkonium chloride soap
Pride Products Corp.

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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PRIDE PRODUCTS - Basics Simply Soft Antibacterial Hand Soap (58037-104)

ACTIVE INGREDIENT

BENZALKONIUM CHLORIDE (0.13% M/M)

PURPOSE

ANTIMICROBIAL

USES

SIMPLY SOFT LIQUID SOAP CLEANS HANDS WITHOUT DRYING YOUR SKIN. PERFECT FOR ALL SKIN TYPES.

WARNINGS

KEEP AWAY FROM DIRECT SUNLIGHT. IN CASE OF CONTACT WITH EYES, RINSE EYES WITH PLENTY OF WATER.

Keep out of reach of children.

DIRECTIONS

WET YOUR HANDS WITH CLEAN WATER. FILL OPEN PALM WITH ONE PUMPFUL OF SIMPLY SOFT LIQUID SOAP. LATHER YOUR HANDS BY RUBBING THEM TOGETHER WITH THE SOAP. RINSE YOUR HANDS UNDER CLEAN, RUNNING WATER.

INACTIVE INGREDIENTS

AQUA (WATER), LAURYL GLUCOSIDE, COCAMIDOPROPYL BETAINE, LAURAMINE OXIDE, GLYCERIN, PEG 120 METHYL GLUCOSE DIOLEATE, CITRIC ACID, PARFUM, TETRASODIUM EDTA, BENZYL ALCOHOL, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, LIMONENE, CITRAL, FD&C YELLOW NO. 6, D&C RED NO. 33.

01b LBL_Antibacterial Hand Soap_500mL

ANTIBACTERIAL HAND
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58037-104
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 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE SODIUM (UNII: MP1J8420LU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CITRAL (UNII: T7EU0O9VPP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58037-104-11	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/06/2021

Labeler - Pride Products Corp. (109020099)