HYGIENE CLEAN PUMPKIN SPICE HAND SANITIZER- benzalkonium chloride liquid 
USA Broom LLC

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.

----------

Hygiene Clean Pumpkin Spice Hand Sanitizer

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:50ml

Bottle

Package Labeling:50ml (24 Bottles)

Bottle2

HYGIENE CLEAN PUMPKIN SPICE HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80499-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
UNDECETH-7 (UNII: R6B5PCO2JN)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80499-008-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product10/30/2020
2NDC:80499-008-0224 in 1 BOX10/30/2020
250 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/30/2020
Labeler - USA Broom LLC (117638854)

Revised: 12/2020
Document Id: b568ab0a-1109-9f0c-e053-2a95a90ab0ce
Set id: b568ab0a-1108-9f0c-e053-2a95a90ab0ce
Version: 1
Effective Time: 20201201
 
USA Broom LLC