APOLLO INSTANT HAND SANITIZER- alcohol gel

Apollo Instant Hand Sanitizer by

Drug Labeling and Warnings

Apollo Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Sbu Group L.P. DBA Apollo Distributors, NINGBO UNICE HOUSEWARES CO. LTD, AOGRAND INTERNATIONAL TRADE CORPORATION, Guangzhou Orchard Aromatherapy & Skin Care Co Ltd, Guangzhou Xuelei Cosmetic Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Uses

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

Warnings

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

Do not apply around eyes. Do not use in ears & mouth.

When using this 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 this 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

Carbomer, Triethanolamine, Glycerin, Water.

Package Labeling :500ml

Package Labeling :237ml

Package Labeling :60ml

Package Labeling :120ml

Package Labeling :5000ml

INGREDIENTS AND APPEARANCE

APOLLO INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78303-000
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78303-000-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
2	NDC: 78303-000-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
3	NDC: 78303-000-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
4	NDC: 78303-000-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
5	NDC: 78303-000-13	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/01/2020

Labeler - Sbu Group L.P. DBA Apollo Distributors (841530095)

Establishment
Name	Address	ID/FEI	Business Operations
NINGBO UNICE HOUSEWARES CO. LTD		412924089	manufacture(78303-000)

Establishment
Name	Address	ID/FEI	Business Operations
AOGRAND INTERNATIONAL TRADE CORPORATION		421353092	manufacture(78303-000)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Orchard Aromatherapy & Skin Care Co Ltd		542355899	manufacture(78303-000)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Xuelei Cosmetic Co., Ltd		526885026	manufacture(78303-000)