HAND SANITIZER WITH ALOE VERA- alcohol gel
Personal Essential Designs, 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.

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Hand Sanitizer Gel With Aloe Vera

Drug Facts

Active Ingredient

Ethyl Alcohol 62% (V/V)

Purpose

Antiseptic

Uses

Hand sanitizer to decrease bacteria on the skin.

Warnings

For external use only - hands

Flammable. Keep away from heat or flame.

When using this product

avoid contact with eyes. In case of contact flush eyes thoroughly with water.

Stop and ask doctor if

skin irritation or redness develops.

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping.
Children under 6 years of age should be supervised when using this product.

Other information

Do not store above 104° F (40° C).
May discolor certain fabrics or surfaces.

Inactive Ingredients

Water (Aqua), Glycerin, Aloe barbadensis Leaf Juice, Carbomer, Triethanolamine, Fragrance

Package Labeling:

Label3

HAND SANITIZER WITH ALOE VERA
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74294-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74294-003-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/01/2020

Labeler - Personal Essential Designs, LLC (080368690)