HAND SANITIZER- alcohol gel

Hand sanitizer by

Drug Labeling and Warnings

Hand sanitizer by is a Otc medication manufactured, distributed, or labeled by STRATEGIC ORIENT SOURCING LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

• Helps reduce bacteria that potentially can cause disease.
• Helps prevent cross contamination by hand contact.
• Recommended for repeated use.

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

• Place enough product on hands to cover all surfaces.
• Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Avoid freezing and excessive heat above 40°C(104°F).
• May discolor certain fabrics.

Inactive ingredients

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

Package Labeling:500ml

Package Labeling:1000ml

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79995-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79995-002-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/10/2020
2	NDC: 79995-002-02	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/10/2020

Labeler - STRATEGIC ORIENT SOURCING LIMITED (667569581)