POLY SAN HAND SANITIZER- isopropyl alcohol liquid

Poly San Hand Sanitizer by

Drug Labeling and Warnings

Poly San Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by US Polychemical Holding Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Qt size 1.jpg

INGREDIENTS AND APPEARANCE

POLY SAN HAND SANITIZER 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76644-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	2.846 L  in 3.785 L

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76644-0001-1	3.785 L in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	06/12/2020
2	NDC: 76644-0001-2	0.946 L in 1 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package	06/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/08/2020

Labeler - US Polychemical Holding Corporation (078395539)

Registrant - US Polychemical Holding Corporation (078395539)

Establishment
Name	Address	ID/FEI	Business Operations
US Polychemical Holding Corporation		078395539	manufacture(76644-0001) , label(76644-0001) , pack(76644-0001) , repack(76644-0001)