HAND SANITIZER- benzalkonium chloride gel
DGH Pharma, Inc.

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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Hand Sanitizer Cu - 32015

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 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 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.

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

product image

Package Label for second product

118 mL Impact Glove

HAND SANITIZER
benzalkonium chloride gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/01/2020

Labeler - DGH Pharma, Inc. (128884560)

Registrant - DGH Pharma, Inc. (128884560)

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