HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Audy Global Enterprises Inc., Zhongrong Technology Corporation Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 67%

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin. Recommended for repeated use.

Warnings

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

WHEN USING

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

STOP USE

Stop use and ask a doctor If irritation redness develop.

If condition persists for more than 72 hours.

Directions

• Place enough product in your palm to thoroughly cover your hands
• Children under 6 years of age should be supervised when using this product
• Rub hands together briskly until dry

Other information

• Protect the product in this container

from excessive heat and direct sun.

• Store below 104°F (40°C)
• May discolor certain fabrics.

Inactive ingredients

Water, Aloe Barbadensis Leaf Juice, Radish Root Ferment Filtrate, Fragrance (parfum), Glycereth-26, Lime (Citrus Aurantifolia) Seed Oil, Lemon (Citrus Limon) Peel Oil, FD&C Red No. 40, FD&C Yellow No. 5, Limonene, Citral, Citronellol, Linalool

Package Label - Principal Display Panel

Package combination of 3 bottles, each bottle contains 45 mL NDC: 75778-006-30

Bottle 1 of 3, Water Melon scent 45 mL NDC: 75778-006-30

Bottle 2 of 3, Citrus scent 45 mL NDC: 75778-006-30

Bottle 3 of 3, Vanilla Cinnamon scent 45 mL NDC: 75778-006-30

Package combination of 3 bottles, each bottle contains 45 mL NDC: 75778-006-31

Bottle 1 of 3, Lavender scent 45 mL NDC: 75778-006-31

Bottle 2 of 3, Mint scent 45 mL NDC: 75778-006-31

Bottle 3 of 3, Aloe Vera scent 45 mL NDC: 75778-006-31

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75778-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	67 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
WATER (UNII: 059QF0KO0R)
CITRUS AURANTIFOLIA SEED OIL (UNII: EW089HAI77)
LEMON OIL, TERPENELESS (UNII: X69W83NI7V)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERETH-26 (UNII: NNE56F2N14)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
CITRAL (UNII: T7EU0O9VPP)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75778-006-30	1 in 1 PACKAGE, COMBINATION	10/25/2021
1		3 in 1 PACKAGE
1		45 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 75778-006-31	1 in 1 PACKAGE, COMBINATION	10/25/2021
2		3 in 1 PACKAGE
2		45 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/14/2021

Labeler - Audy Global Enterprises Inc. (079171473)

Establishment
Name	Address	ID/FEI	Business Operations
Zhongrong Technology Corporation Ltd.		529575698	manufacture(75778-006)