HAND SANITIZER- hand sanitizer 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, phenoxyethanol, fragrance(parfum), hydroxyethylcelltulose, alcohol, limonene, linalool, citral, citronellol eugenol, geraniol.

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 children under 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
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81726-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1235 g in 95 mL

Ingredient Name	Strength
Inactive Ingredients
EUGENOL (UNII: 3T8H1794QW)
GERANIOL (UNII: L837108USY)
FRAGRANCE EUCALYPTUS SPEARMINT ORC1601627 (UNII: E90O5M6HMB)
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CITRAL (UNII: T7EU0O9VPP)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81726-007-01	95 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/12/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/12/2021

Labeler - The Source Design Collections (527929622)

Name	Address	ID/FEI	Business Operations
Establishment
The Source Design Collections		527929622	manufacture(81726-007)