Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Warnings

For external use only.
Keep out of eyes. In case of contact, flush eyes water.
Stop use and consult a doctor if irritation or redness develops.

Uses

• To decrease bacteria on the skin.

Directions

•Rub thoroughly over all surfaces of both hands.
•Rub hands together briskly until dry.

Keep out of reach of children.

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

Inactive ingredients:

water, Cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, propylene glycol, diazolidinyl urea, methyl paraben, propylparaben, citric acid, dihydroxypropyl, PEG-5 linoleammonium.

Product Label

image description

HAND SANITIZER
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71120-112
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71120-112-01	18 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/06/2020
2	NDC:71120-112-04	50 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/06/2020
3	NDC:71120-112-05	1000 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/06/2020
4	NDC:71120-112-06	550 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/06/2020
5	NDC:71120-112-07	250 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/06/2020
6	NDC:71120-112-08	300 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/06/2020
7	NDC:71120-112-09	3785 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/06/2020
8	NDC:71120-112-10	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/06/2020
9	NDC:71120-112-11	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/06/2020
10	NDC:71120-112-02	24 in 1 PACKAGE	10/06/2020
10		18 mL in 1 CONTAINER; Type 0: Not a Combination Product
11	NDC:71120-112-03	48 in 1 PACKAGE	10/06/2020
11		18 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/06/2020

Labeler - Sanit Technologies LLC (075711022)

Name	Address	ID/FEI	Business Operations
Establishment
Durisan		085479946	manufacture(71120-112)

18ml Hand Sanitizer Credit Card Sprayer