HAND SANITIZER- benzalkonium chloride lotion

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Harmonia de Venezuela CA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient                                                        Purpose

Benzalkonium Chloride (0.1 %)--------------------- Antimicrobial

PURPOSE

Uses

For hand sanitizing to decrease bacteria on the skin.

Warnings

For external uses only. / When using this products avoid contact of eyes. In case of eye contact, flush eyes with water. / Stop use and ask a doctor if irritation or redness develops, or if conditions 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

Apply a small amount into palm of hands and rub hands together briskly until dry.

KEEP OUT OF REACH OF CHILDREN

Inactive Ingredients

water, glycerin, stearic acid, cetostearyl alcohol, mineral oil, propylene glycol, trietanolamine, benzophenone-3, polysorbate 60, PEG 12-
dimethicone, glyceryl stearate, fragance, imidazolidinyl urea, propyl paraben, carbomer, tocopheryl acetate, tetrasodium EDTA, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1 , FD&C Red No. 40.

Principal display panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73360-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
OXYBENZONE (UNII: 95OOS7VE0Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
IMIDUREA (UNII: M629807ATL)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73360-001-01	4 in 1 CARTON	09/20/2019
1		28 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 73360-001-02	28 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/20/2019

Labeler - Harmonia de Venezuela CA (817307290)

Establishment
Name	Address	ID/FEI	Business Operations
Harmonia de Venezuela CA		817307290	manufacture(73360-001)