HAND SANITIZER- alcohol gel 
STRATEGIC ORIENT SOURCING LIMITED

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

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Do not use

  • On children less than 2 months of age or on open skin wounds.

When using this product

  • Keep out of eyes and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and see a doctor

if irritation or redness develops.

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Water, Glycerin, Aloe Barbadensis Extract, Aminomethyl Propanol, Carbomer, Fragrance, Tocopherol.

Package Labeling:500ml

Label

Package Labeling:1000ml

Label2

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79995-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79995-002-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/10/2020
2NDC:79995-002-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/10/2020
Labeler - STRATEGIC ORIENT SOURCING LIMITED (667569581)

Revised: 8/2020
Document Id: ac27eda2-dbb1-109a-e053-2995a90aa9da
Set id: 17cff022-8c85-4211-b872-6a9a7895e5fa
Version: 1
Effective Time: 20200805
 
STRATEGIC ORIENT SOURCING LIMITED