Circle B Manufacturing Foaming Alcohol Free Hand Sanitizer: Package Insert and Label Information

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.

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

Package Labeling:

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER LAURAMINE OXIDE UNDECETH-7 EDETATE DISODIUM ANHYDROUS DMDM HYDANTOIN CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:81458-000-01 3790 mL in 1 BOTTLE None 2 NDC:81458-000-02 4 BOTTLE in 1 PACKAGE contains a BOTTLE 2 3790 mL in 1 BOTTLE This package is contained within the PACKAGE (81458-000-02)

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

Labeler — Circle B Manufacturing, Inc. (117798339)

Revised: 02/2021 Circle B Manufacturing, Inc.