HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by WESSCO International, Zhejiang iColor Biotech Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce germs on the skin.

Warnings

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

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product: avoid contact with eyes. lf contact occurs, rinse thoroughly with water.

STOP USE

Stop using and ask a doctor if irritation or redness develops and lasts.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: ln case of accidental ingestion, get medical help or contact a poison control center immediately.

Directions

• Squeeze a significant amount in your palm and rub hands until fully dry.
• Rinse free.

Other information

• Store below 110 °F（43° C).

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl propanol, Aloe Barbadensis leaf Juice, Denatonium benzoate, Fragrance, Glycerin, Maltodextrin, Propylene Glycol, Tocopheryl Acetate, Water.

Package Label - Principal Display Panel

1000 mL NDC: 42509-036-01

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42509-036
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
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42509-036-01	1000 mL in 1 BAG; Type 0: Not a Combination Product	02/19/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/19/2021

Labeler - WESSCO International (118553619)

Establishment
Name	Address	ID/FEI	Business Operations
WESSCO International		118553619	label(42509-036)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang iColor Biotech Co., Ltd		554528308	manufacture(42509-036)