D7 Foaming Hand Sanitizer

D7 Foaming Hand Sanitizer by

Drug Labeling and Warnings

D7 Foaming Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Decon7 Systems, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

D7 FOAMING HAND SANITIZER- benzalkonium chloride liquid 
Decon7 Systems, LLC

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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D7 Foaming Hand Sanitizer

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

• For hand sanitizing to decrease bacteria on the skin
• Recommended for repeated use

Warnings

For external use only

When using this product avoid contact with the eyes. In case of eye contact, flush eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develop or last more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply small amount of foam into palm of hand
• Rub hands together briskly covering surface of hands until dry

Inactive Ingredients

Water, cocamidopropyl PG-dimonium chloride phosphate, dihydroxyethyl cocamine oxide, acetamidoethoxyethanol, citric acid, fragrance

Decon7 Antiseptic

Foaming Hand Sanitizer

Manufactured in the USA for: D7 / Decon Seven

8541 E Anderson Drive, Suite 106

Scottsdale, AZ 85255

844-727-FOAM

info@decon7.com

24/7 Emergency Response,

Contact Chemtrec 800-424-9300

D7 FOAMING HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78245-100
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
ACETAMIDOETHOXYETHANOL (UNII: LVX2APC4XR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78245-100-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020	12/22/2021
2	NDC: 78245-100-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020	12/22/2021
3	NDC: 78245-100-03	1000 mL in 1 BAG; Type 0: Not a Combination Product	07/06/2020	12/22/2021
4	NDC: 78245-100-04	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020	12/22/2021
5	NDC: 78245-100-05	1040988 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/06/2020	12/22/2021
6	NDC: 78245-100-07	550 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/25/2020	12/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/06/2020	12/22/2021

Labeler - Decon7 Systems, LLC (079281162)

Establishment
Name	Address	ID/FEI	Business Operations
Decon7 Systems, LLC		079281162	manufacture(78245-100)

Revised: 12/2021

Document Id: d3bff562-f38c-58a5-e053-2a95a90a56d5

34390-5

Set id: a9cc027b-295e-4b36-e053-2a95a90a45ce

Version: 4

Effective Time: 20211222