ELEMENT CONTROL RINSE FREE HAND SANITIZER SOOTHING- alcohol gel

Element Control Rinse Free Hand Sanitizer Soothing by

Drug Labeling and Warnings

Element Control Rinse Free Hand Sanitizer Soothing 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%

Purpose

Antiseptic

Use

• 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 

• in 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 ask a doctor

• if irritation and redness develop

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, Propylene Glycol, Carbomer, Fragrance, Tocopherol.

Package Labeling:

INGREDIENTS AND APPEARANCE

ELEMENT CONTROL RINSE FREE HAND SANITIZER SOOTHING 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79995-027
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)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79995-027-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/25/2020

Labeler - Strategic Orient Sourcing Limited (667569581)