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

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

Aloe Barbadensis Leaf Juice, Citrus Sinensis (Orange) Fruit Oil, Cocamidopropyl PG-Dimonium Chloride Phosphate, Glycerin, Hydroxyethylcellulose, PEG-8, PEG-90, Potassium Sorbate, Polysorbate 20, Purified Water, Quercus Borealis Bark Extract

Package Label - Principal Display Panel

118 mL Sanitizer Label

Impact Diversity Solutions Label

118 mL Impact Sanitizer

HAND SANITIZER
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77238-221
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
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)	2.2 g in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	1.8 g in 100 mL
WATER (UNII: 059QF0KO0R)
QUERCUS RUBRA BARK (UNII: X26K8566JX)	1 g in 100 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.2 g in 100 mL
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)	1 g in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	1 g in 100 mL
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)	0.7 g in 100 mL
ORANGE OIL (UNII: AKN3KSD11B)	0.1 g in 100 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.05 g in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77238-221-14	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/22/2020
2	NDC:77238-221-24	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/05/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/22/2020

Labeler - DGH Pharma, Inc. (128884560)

Registrant - DGH Pharma, Inc. (128884560)

Name	Address	ID/FEI	Business Operations
Establishment
DGH Pharma, Inc.		128884560	manufacture(77238-221)