HAND SANITIZER- alcohol gel
Aventi Medical, 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

Drug Facts

Active ingredients

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

For handwashing to decrease bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame. For external use only.

When using this product

Do not use in eyes. In case of contact with eyes, rinse with water.

Stop use and ask a doctor

if irritation and redness develop and persist.

Keep out of reach of children.

If swallowed, get medical help promptly.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other information

Store under 105 oF

Inactive ingredients

Aloe Barbadensis Leaf, Carbomer, Dimethicone, Triisopropanolamine, Water

Package Labeling: 1000L, 77811-001-01

1000

Package Labeling: 3785mL, 77811-001-02

3785

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77811-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77811-001-01	1000000 mL in 1 CONTAINER; Type 0: Not a Combination Product	05/21/2020
2	NDC:77811-001-02	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/21/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/21/2020

Labeler - Aventi Medical, LLC (117518869)