ALOE VERA HAND SANITIZER HANDSANTTIZER- handsanttizer gel
XIAMEN EASEPAL ENTERPRISES LIMITED

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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Flammable. Keep away from fire or flame.

Directions. Put enough product in your palm to cover your hands completely. Rub hands together, covering all surfaces for approx. 25 seconds or until your hands are dry. Children under 6 years of age should be supervised when using this product.

Store at 60'°F to 77°F (16°C to 25°C).

May discolor certain fabrics or surfaces.

Disinfection
Sterilization
No Rinseing

Water, Glycerin, Carbomer, Triethanolamine.

Fragrance(Parfum) Lemon, Aloe Barbadensis Leaf Extract

Ethyl Alcohol 65.00%..

keep out of reach of children.

label

ALOE VERA HAND SANITIZER HANDSANTTIZER
handsanttizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67984-001
Route of Administration	EXTRACORPOREAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	58.5 mL in 90 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
LEMON (UNII: 24RS0A988O)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	Score
Shape	Size
Flavor	Imprint Code	seasonguard
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67984-001-01	90 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/25/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/25/2020

Labeler - XIAMEN EASEPAL ENTERPRISES LIMITED (679849096)

Name	Address	ID/FEI	Business Operations
Establishment
XIAMEN EASEPAL ENTERPRISES LIMITED		679849096	manufacture(67984-001)