SOLDANIZER DN-723- benzalkonium chloride spray
3VETS 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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3VETS LLC - SOLDANIZER DN-723, MULTI-PURPOSE HAND SANITIZER (77015-100)

ACTIVE INGREDIENT

BENZALKONIUM CHLORIDE 0.13%

PURPOSE

ANTIMICROBIAL

USES

HAND SANITIZER HELPS REDUCE BACTERIA ON THE SKIN.
CAN BE USED REPEATEDLY.

WARNINGS

FOR EXTERNAL USE ONLY.

AVOID CONTACT WITH OR NEAR EYES WHEN USING THIS PRODUCT. IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER.

IF IRRITATION OR RASH APPEARS, OR IF CONDITION PERSISTS, STOP USE AND CONTACT A DOCTOR.

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

SPRAY PRODUCT INTO THE PALM OF HAND.
RUB HANDS TOGETHER THOROUGHLY UNTIL DRY.
SUPERVISE CHILDREN UNDER 6 YEARS OF AGE WHEN USING PRODUCT.

INACTIVE INGREDIENTS

WATER, DIDECYL DIMETHYL AMMONIUM CHLORIDE, PROPYLENE GLYCOL, METHYLPARABEN, DIAZOLIDINYL UREA, PROPYLPARABEN, COCAMIDOPROPYLAMINE OXIDE, ALLANTOIN, COCAMIDOPROPYL BETAINE, CETRIMONIUM CHLORIDE, TRIETHANOLAMINE, CITRIC ACID.

LABEL

SOLDANIZER DN-723
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77015-100
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)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
ALLANTOIN (UNII: 344S277G0Z)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
TROLAMINE (UNII: 9O3K93S3TK)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77015-100-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/20/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/20/2021

Labeler - 3VETS LLC (117147912)