HYGIENE CLEAN CLEAN COTTON HAND SANITIZER- benzalkonium chloride liquid

Hygiene Clean Clean Cotton Hand Sanitizer by

Drug Labeling and Warnings

Hygiene Clean Clean Cotton Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by USA Broom LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

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 briskly until dry

Inactive Ingredients:

Water, Propylene Glycol, Lauramine Oxide, Undecth-7, Disodium EDTA; Aloe Barbadensis Gel, Glycereth-2-Cocoate; DMDM Hydantoin; Fragrance, Citric Acid

Package Labeling:237 ml

Package Labeling:5.68l

Package Labeling:50ml

Package Labeling:1.2L

INGREDIENTS AND APPEARANCE

HYGIENE CLEAN CLEAN COTTON HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80499-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
UNDECETH-7 (UNII: R6B5PCO2JN)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80499-001-01	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2020
2	NDC: 80499-001-02	24 in 1 BOX	09/30/2020
2	NDC: 80499-001-01	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 80499-001-03	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2020
4	NDC: 80499-001-04	24 in 1 BOX	09/30/2020
4		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	09/30/2020

Labeler - USA Broom LLC (117638854)