HAND SANITIZER- alcohol gel

Hand sanitizer by

Drug Labeling and Warnings

Hand sanitizer by is a Otc medication manufactured, distributed, or labeled by PurCel Labs LLC, Jiangsu Intco Medical Products Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 70% v/v

Purpose

Antiseptic

Uses

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

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

WHEN USING

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

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

Children under 6 years of age should be supervised when using products.

Other information

Store below 110°F (43°C).

Avoid freezing and excessive heat above 104°F (40°C).

May discolor certain fabrics or surfaces.

Inactive ingredients

Aloe Vera, Carbomer Interpolymer (type B),Lemon oil,Glycerin,Triethanolamine, Water (Aqua).

Package label.principal display panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83584-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LEMON OIL (UNII: I9GRO824LL)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83584-002-02	200 in 1 CARTON	08/06/2023
1	NDC: 83584-002-01	59 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/06/2023

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83584-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LEMON OIL (UNII: I9GRO824LL)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83584-116-02	30 in 1 CARTON	08/06/2023
1	NDC: 83584-116-01	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/06/2023

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83584-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LEMON OIL (UNII: I9GRO824LL)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83584-004-02	100 in 1 BOTTLE, PUMP	08/06/2023
1	NDC: 83584-004-01	118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/06/2023

Labeler - PurCel Labs LLC (127672531)

Registrant - Jiangsu Intco Medical Products Co., Ltd (529128686)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Intco Medical Products Co., Ltd		529128686	manufacture(83584-116, 83584-002, 83584-004)