APOLLO INSTANT HAND SANITIZER- alcohol gel 
Sbu Group L.P. DBA Apollo Distributors

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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Apollo Instant Hand Sanitizer

Drug Facts

Active ingredient

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Uses

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

Other information

Inactive ingredients

Carbomer, Triethanolamine, Glycerin, Water.

Package Labeling :500ml

Label5

Package Labeling :237ml

Label4

Package Labeling :60ml

Label2

Package Labeling :120ml

Label3

Package Labeling :5000ml

Label

APOLLO INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78303-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75   in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78303-000-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
2NDC:78303-000-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
3NDC:78303-000-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
4NDC:78303-000-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
5NDC:78303-000-135000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/2020
Labeler - Sbu Group L.P. DBA Apollo Distributors (841530095)
Establishment
NameAddressID/FEIBusiness Operations
NINGBO UNICE HOUSEWARES CO. LTD412924089manufacture(78303-000)
Establishment
NameAddressID/FEIBusiness Operations
AOGRAND INTERNATIONAL TRADE CORPORATION421353092manufacture(78303-000)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Orchard Aromatherapy & Skin Care Co Ltd542355899manufacture(78303-000)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Xuelei Cosmetic Co., Ltd526885026manufacture(78303-000)

Revised: 7/2020
Document Id: aa684bea-80d2-e56c-e053-2995a90a24a4
Set id: b4100cc4-1458-4a9c-8bb5-a5ad5d3372a3
Version: 2
Effective Time: 20200714
 
Sbu Group L.P. DBA Apollo Distributors