HAND SANITIZER- alcohol liquid 
HANGZHOU AROMA ELECTRONIC COMMERCE CO.,LTD

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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HAND SANITIZER

Active Ingredient

Alcohol 68% Purpose: Antiseptic

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Inactive ingredients

Deionized water,Aloe Barbadensis Gel,Fragrance,Glycerin,Propylene Glycol,Carbomer,Trolamine,FD&C Red 4#,FD&C Yellow 5#,FD&C Blue 1#.

Package Label - Principal Display Panel

package

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78881-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
DIHYDRO PENTAMETHYLINDANONE (UNII: BZR4438MY4)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78881-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product06/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/09/2020
Labeler - HANGZHOU AROMA ELECTRONIC COMMERCE CO.,LTD (547703131)
Establishment
NameAddressID/FEIBusiness Operations
HANGZHOU AROMA ELECTRONIC COMMERCE CO.,LTD547703131manufacture(78881-001)

Revised: 6/2020
Document Id: a79e1d50-e424-1349-e053-2a95a90a5c4f
Set id: a79e1d50-e432-1349-e053-2a95a90a5c4f
Version: 1
Effective Time: 20200608
 
HANGZHOU AROMA ELECTRONIC COMMERCE CO.,LTD