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, Undeceth-7; Disodium EDTA; Aloe Barbadensis Gel; Glycereth-2-Cocoate; DMDM Hydantoin; Fragrance, Citric Acid

Package Labeling:(237 ml)

Label7

Package Labeling:(237 ml) - 24 bottles

Label8

HYGIENE CLEAN PUMPKIN SPICE HAND SANITIZER ALCOHOL FREE
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80499-007
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80499-007-01	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2020
2	NDC:80499-007-02	24 in 1 BOX	09/30/2020
2		237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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

Labeler - USA Broom LLC (117638854)

Hygiene Clean Pumpkin Spice Hand Sanitizer Alcohol Free