POLY SAN HAND SANITIZER- isopropyl alcohol liquid 
US Polychemical Holding Corporation

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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Poly San Liquid Hand Sanitizer
(Isopropyl Alcohol based  Hand Sanitizer)

Poly San Hand Sanitizer;  Purpose

Purpose: Antimicrobial 

Poly San Hand Sanitizer; Active Ingredient Section

Active Ingredient: Isopropyl Alcohol.....75%(v/v)

Poly San Hand Sanitizer; Indications & Usage Section

Use: Hand sanitizer tTo help reduce the amount of bacteria on the skin.

Poly San Hand Sanitzer; Do Not Use Section

For external use only,do not use

• on children less than 2 months of age

• on an open skin wound

• in or near the eyes, ears or mouth

In case of contact, rinse eyes thoroughly with water

Poly San Hand Sanitzer; Warnings  Section

Warnings: Flammable, keep away from fire or flame.

Poly San Hand Sanitizer Gel; Stop use and ask Doctor if section 

Stop use and ask Doctor if irritation appears and lasts

Poly San Hand Sanitizer; Keep out of reach of children section

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

Poly San Hand Sanitizer; Dosage & Administration Section

Directions: Put enough of the product in your palm to cover hands and rub hands together briskly until dry.

Children under the age of 6 should be supervised when using this product

Poly San Hand Sanitizer; Inactive Ingredient Section

Inactive ingredients: Water(Aqua), glycerol, Fragrance (Parfum)

Poly San Hand Sanitizer Gel; Other Safety Information 

Other information: At or below 110°F (43°C) may discolor certain fabrics or surfaces.

Avoid freezing and excessive heat.

Store between 59-86°F (15-30°C).

Poly San Hand Sanitzer Drug Facts Label 

The following Hand sanitizer is manufactured according to the 1994 TFM for OTC antiseptic drug products that published in the Federal Register of June 17, 1994 (59 FR 31402).

Drug Facts

Active Ingredient: Isopropanol 75% (v/v)  Purpose: Antimicrobial

Use: Hand sanitizer to help reduce bacteria on skin

Warnings: Flammable, keep away from fire or flame.

For external use only, do not use

• on children less than 2 months of age

• on an open skin wound

• in or near the eyes, ears or mouth

In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if irritation or rash appears and lasts

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

Directions: Put enough of the product in your palm to cover hands and rub hands together briskly until dry

Children under the age of 6 should be supervised when using this product

Other information: At or below 110°F (43°C) may discolor certain fabrics or surfaces.

Avoid freezing and excessive heat.

Store between 59-86°F (15-30°C).

Inactive ingredients: Water(Aqua),glycerol, fragrance (Parfum)

Poly San Hand Sanitizer Gallon Size 1.jpg

Poly San Hand Sanitizer Gallon Size 1.jpg

Poly San Hand Sanitizer Qt size 1.jpg

Poly San Hand Sanitizer Qt size 1.jpg

POLY SAN HAND SANITIZER 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76644-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL2.846 L  in 3.785 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 0.86 L  in 3.785 L
GLYCERIN (UNII: PDC6A3C0OX) 0.076 L  in 3.785 L
COUMARIN (UNII: A4VZ22K1WT) 0.000001445 L  in 3.785 L
HEXAMETHYLINDANOPYRAN (UNII: 14170060AT) 0.00001445 L  in 3.785 L
TERPINEOL (UNII: R53Q4ZWC99) 0.00001445 L  in 3.785 L
BENZYL ACETATE (UNII: 0ECG3V79ZJ) 0.000007225 L  in 3.785 L
TERPINYL ACETATE (UNII: NIT9SZT3D7) 0.000007225 L  in 3.785 L
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) 0.00001445 L  in 3.785 L
CINNAMYL ALCOHOL (UNII: SS8YOP444F) 0.000001445 L  in 3.785 L
DECANAL (UNII: 31Z90Q7KQJ) 0.000001445 L  in 3.785 L
PHENYLACETALDEHYDE (UNII: U8J5PLW9MR) 0.000001445 L  in 3.785 L
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) 0.000001445 L  in 3.785 L
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) 0.00001445 L  in 3.785 L
GERANIOL (UNII: L837108USY) 0.00001445 L  in 3.785 L
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) 0.00001445 L  in 3.785 L
LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.00000289 L  in 3.785 L
4-TERT-BUTYLCYCLOHEXANYL ACETATE, TRANS- (UNII: ATR4EHD017) 0.0000289 L  in 3.785 L
EUGENOL (UNII: 3T8H1794QW) 0.000001445 L  in 3.785 L
DIHYDROMYRCENOL (UNII: 46L1B02ND9) 0.000001445 L  in 3.785 L
LINALYL ACETATE, (+)- (UNII: 3ID3M89AV9) 0.000001445 L  in 3.785 L
LIMONENE, (+/-)- (UNII: 9MC3I34447) 0.00000578 L  in 3.785 L
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) 0.000001445 L  in 3.785 L
3,3'-DIHYDROXYDIPROPYL ETHER (UNII: S1OQ81LMNA) 0.00007225 L  in 3.785 L
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76644-0001-13.785 L in 1 BOTTLE; Type 1: Convenience Kit of Co-Package06/12/2020
2NDC:76644-0001-20.946 L in 1 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package06/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/08/2020
Labeler - US Polychemical Holding Corporation (078395539)
Registrant - US Polychemical Holding Corporation (078395539)
Establishment
NameAddressID/FEIBusiness Operations
US Polychemical Holding Corporation078395539manufacture(76644-0001) , label(76644-0001) , pack(76644-0001) , repack(76644-0001)

Revised: 4/2020
Document Id: d976b100-f43c-4efa-8011-9040721eae23
Set id: 6b2f07f0-3b56-451b-bd21-0c0e784e713b
Version: 1
Effective Time: 20200430
 
US Polychemical Holding Corporation