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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Instant Hand Sanitizer

Drug Facts

Active ingredients

Ethyl / Alcohol 75% v/v

Purpose

Antiseptic

Uses

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

Other information

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

Label

INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78303-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78303-003-003785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/15/2020
Labeler - SBU GROUP L.P.DBA APOLLO DISTRIBUTORS (841530095)
Establishment
NameAddressID/FEIBusiness Operations
Aogrand International Trade Corporation421353092manufacture(78303-003)
Establishment
NameAddressID/FEIBusiness Operations
GUANGZHOU XUELEI COSMETIC CO LTD526885026manufacture(78303-003)

Revised: 7/2020
Document Id: aa68198c-b657-067d-e053-2995a90ae93a
Set id: 335955d4-17e3-4576-b625-a9cb30954eeb
Version: 3
Effective Time: 20200714
 
SBU GROUP L.P.DBA APOLLO DISTRIBUTORS