reddot by Hankscraft Inc. / Decon7 Systems, LLC

reddot by

Drug Labeling and Warnings

reddot by is a Otc medication manufactured, distributed, or labeled by Hankscraft Inc., Decon7 Systems, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

REDDOT- hand sanitizer liquid 
Hankscraft 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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Directions

• Receive appropriate amount of sanitizer to palm of hand. Rub thoroughly over all surfaces of both hands. Continue to rub hands together until dry.

Keep out of reach of children. Eye irritant. In case of contact, immediately flush eyes for 15 minutes. If irritation persists, get medical attention. Harmful if swallowed.

Active Ingredient(s)

Benzalkonium Chloride 0.1% . . . . . . . . . Antimicrobial

Use

• Recommended for repeated use

Purpose

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 eyes. In case of eye contact, flush eyes with water
• Stop use and ask a doctor if irritation or redness develops, and if condition persists for more than 72 hours.

Keep out of reach of children

In case of accidental ingestion, seek medical attention or contact poison control right away

Directions

• Pump a small amount of foam into palm of hand
• Rub thoroughly over all surfaces of both hands
• Rub hands together briskly until dry

Inactive Ingredients

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

Questions

Contact RedDot Brands Mon-Fri 9am-5pm EST at 608-524-4341

Package Label - Principal Display Panel

REORDER: DC7000

Manufactured for:

Hankscraft, Inc./ dba RedDot Brands

300 Wengel Drive

Reedsburg, WI 53959

608-524-4341

www.reddotbrands.com

Foaming Non-Alcohol Hand Sanitizer

with Benzalkonium Chloride

Alcohol-Free

Foaming

Hand Sanitizer

reddot

Net Contents: 1000 mL NDC: 70828-028-01

REDDOT 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70828-028(NDC: 78245-200)
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
ACETAMIDOETHOXYETHANOL (UNII: LVX2APC4XR)	1 mg  in 1 mL
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)	1 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	1 mg  in 1 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	1 mo  in 1 mL
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)	1 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70828-028-01	1000 mL in 1 BAG; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	12/30/2022

Labeler - Hankscraft Inc. (802894337)

Establishment
Name	Address	ID/FEI	Business Operations
Decon7 Systems, LLC		079281162	manufacture(70828-028)

Establishment
Name	Address	ID/FEI	Business Operations
Hankscraft Inc.		802894337	repack(70828-028)

Revised: 3/2023

Document Id: f606b1d3-26b1-b679-e053-2995a90a4e9f

34390-5

Set id: ae45cd5f-ca9e-0f07-e053-2995a90ad3d5

Version: 2

Effective Time: 20230303