INSTANT HAND SANITIZER- alcohol gel

Instant Hand Sanitizer by

Drug Labeling and Warnings

Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by SBU GROUP L.P.DBA APOLLO DISTRIBUTORS, Aogrand International Trade Corporation, GUANGZHOU XUELEI COSMETIC CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Ethyl / Alcohol 75% v/v

Purpose

Antiseptic

Uses

• Hand sanitizer to help decrease bacterial on the skin, when water, soap & towel are not available.
• Recommended for repeated use.

Warnings

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

Do not apply around eyes.

Do not use

Do not use in ears & mouth.

When using product,

Avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor

if redness or irritation develop and persists for more than 72 hours.

Keep out of reach of children.

Children must be supervised in use of htis product.

Directions

• Place enough product into your palms and thoroughly spread on both hands.
• Rub into skin until dry.

Other information

• Store below 110 °F (43 °C).
• May discolor certain fabrics or surfaces.

Inactive ingredients

Glycerin, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer Fragrance Aminomethyl Propanol, Propylene Glycol, Tocopherol, Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Lactic Acid, Citric acid.

Package Labeling

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78303-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ETHYLENE GLYCOL (UNII: FC72KVT52F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78303-003-00	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/15/2020

Labeler - SBU GROUP L.P.DBA APOLLO DISTRIBUTORS (841530095)

Establishment
Name	Address	ID/FEI	Business Operations
Aogrand International Trade Corporation		421353092	manufacture(78303-003)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGZHOU XUELEI COSMETIC CO LTD		526885026	manufacture(78303-003)