CIRCLE B MANUFACTURING FOAMING ALCOHOL FREE HAND SANITIZER- benzalkonium chloride liquid
Circle B Manufacturing, 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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Circle B manufacturing foaming alcohol free Hand sanitizer

Drug Facts

Active ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

- For hand sanitizing to decrease the bacteria on 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, or if condition persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control center right away.

DIRECTIONS

- Pump a small amount of foam into palm of hand
- Rub thoroughly over all surfaces of both hands
- Rub hands together to produce a thick lather

Inactive ingredients:

Water, Lauramine Oxide, Undeceth-7, Disodium EDTA, DMDM Hydantoin, Fragrance, Citric Acid, FD&C Red #33, FD&C Blue #1.

Package Labeling:3790ml

Bottle

Package Labeling:

Bottle2

CIRCLE B MANUFACTURING FOAMING ALCOHOL FREE HAND SANITIZER
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81458-000
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
UNDECETH-7 (UNII: R6B5PCO2JN)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:81458-000-01	3790 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/19/2020
2	NDC:81458-000-02	4 in 1 PACKAGE	08/19/2020
2		3790 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/19/2020

Labeler - Circle B Manufacturing, Inc. (117798339)