HAND SANITIZER- benzalkonium chloride spray
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 Spray - 32016

Active Ingredient(s)

Benzalkonium Chloride 0.10% w/w. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Spray on mask and hands to sanitize & protect against bacteria and pathogens.

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

Spray on hands and on each side of your mask

Inactive ingredients

D-Limonene, Copper Chloide, Glycerin, Magnesium Hydroxide, PEG-8, PEG-90, Phenoxyethanol, Polysorbate 20, Purified Water, Trisodium Citrate

Package Label - Principal Display Panel

product image

Additional Label

30 mL Spray

HAND SANITIZER
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77238-241
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)	0.21 g in 100 mL
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)	0.21 g in 100 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.2 g in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.4 g in 100 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)	0.005 g in 100 mL
CUPRIC CHLORIDE (UNII: S2QG84156O)	0.267 g in 100 mL
LIMONENE, (+)- (UNII: GFD7C86Q1W)	0.1 g in 100 mL
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)	0.15 g in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77238-241-11	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
2	NDC:77238-241-21	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/05/2020
3	NDC:77238-241-41	30 mL in 1 BOTTLE; 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(77238-241)