WIPE OUT ANTIBACTERIAL LIQUID HAND LAVENDER SCENT- benzalkonium chloride soap
TZUMI INNOVATIONS 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.

----------

77878-029, Style: WP0024 LAV

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

For hand washing to decrease bacteria on the skin

Warnings

For external use only

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands
Apply palmful to hands
Scrub thoroughly for at least 15 seconds
Rinse thoroughly and dry

Inactive ingredients

Water, Cocamidopropyl dimethylamine oxide, Citric Acid, Fragrance, Kathon, Glycerin, Fatty acyl diethanol amine, Disodium EDTA, Hydroxyethyl Cellulose (250HHR), Blue 1 (CI 42090), CI 18134

image description

WIPE OUT ANTIBACTERIAL LIQUID HAND LAVENDER SCENT
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77878-029
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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
DISODIUM HEDTA (UNII: KME849MC7A)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77878-029-01	221 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/23/2020

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

Labeler - TZUMI INNOVATIONS LLC (117426322)

Name	Address	ID/FEI	Business Operations
Establishment
Aogrand International Trade Corporation		421353092	manufacture(77878-029)