HAND SANITIZER- benzalkonium chloride gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by DGH Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride 0.10% w/w. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

To eliminate viruses and bacteria on the skin

Warnings

For external use only.

WHEN USING

When using this product keep out of eyes. In case of contact, flush eyes with water.



Stop use and ask a doctor if irritation or redness develops



Keep out of reach of children. If swallowed, get medical assistance or contact a Poison Control Center immediately.

STOP USE

Stop use and ask a doctor if irritation or redness develops.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical assistance or contact a Poison Control Center immediately.

Directions

• Rub thoroughly over all surfaces of both hands.
• Rub hands toghether briskly unitl dry.

Inactive ingredients

Citrus Sinensis (Orange) Fruit Oil, Copper Chloride, Glycerin, Hydroxyethylcellulose, Magnesium Hydroxide, PEG-8, PEG-90, Phenoxyethanol, Polysorbate 20, Purified Water

Package Label - Principal Display Panel

Package Label for second product

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77238-231
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CUPRIC CHLORIDE (UNII: S2QG84156O)	0.201 g  in 100 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)	0.05 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.65 g  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.4 g  in 100 mL
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)	1.95 g  in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	1.65 g  in 100 mL
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)	2 g  in 100 mL
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)	0.65 g  in 100 mL
LIMONENE, (+)- (UNII: GFD7C86Q1W)	0.18 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77238-231-14	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
2	NDC: 77238-231-24	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/06/2020
3	NDC: 77238-231-11	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/2020
4	NDC: 77238-231-31	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/01/2022
5	NDC: 77238-231-41	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/01/2022
6	NDC: 77238-231-44	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2022
7	NDC: 77238-231-48	3785 mL in 1 JUG; Type 0: Not a Combination Product	07/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2020

Labeler - DGH Pharma, Inc. (128884560)

Registrant - DGH Pharma, Inc. (128884560)

Establishment
Name	Address	ID/FEI	Business Operations
DGH Pharma, Inc.		128884560	manufacture(77238-231)