HAND SANITIZER GEL- hand sanitizer gel gel 
The Source Design Collections

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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Benzalkonium Chloride 0.13%

Antiseptic

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Water(aqua), propylene glycol, hydroxyethylcellulose, phenoxyethanol, fragrance(parfum)(Lavender ORC1800979)，alcohol, linalool

Directions

Place enough product on hands to cover all surfaces.Rub hands together until dry.

For external use only.

Do not use on open skin wounds or childrenunder 2 months of age.

When using this product keep out of eyes,ears, and mouth. ln case of contact with eyes,rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

Other information

Store in a cool dry place, away from direct sunlight and heat.

label

HAND SANITIZER GEL 
hand sanitizer gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81726-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
WATER (UNII: 059QF0KO0R)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FRAGRANCE LAVENDER ORC1800979 (UNII: 1B40MIN2W5)  
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81726-001-01100 mL in 1 TUBE; Type 0: Not a Combination Product03/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/31/2021
Labeler - The Source Design Collections (527929622)
Establishment
NameAddressID/FEIBusiness Operations
The Source Design Collections527929622manufacture(81726-001)

Revised: 4/2021
Document Id: c010e19b-2f17-16e4-e053-2a95a90a2c8b
Set id: bed00f85-0400-2bad-e053-2a95a90a715b
Version: 2
Effective Time: 20210416
 
The Source Design Collections