SHIELDPLEX HAND SANITIZER- alcohol gel

Shieldplex Hand Sanitizer by

Drug Labeling and Warnings

Shieldplex Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by CLT Logistics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl alcohol 75% v/v.

Purpose

Antiseptic

Use

To help reduce bacteria 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 this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

Place enough product on hands to cover all surfaces. Rub hands together for 15 seconds until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Glycerin, Hydrogen Peroxide, Denatonium Benzoate, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Distilled Water, Fragrance.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

SHIELDPLEX HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75490-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75490-007-01	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/03/2020
2	NDC: 75490-007-02	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/03/2020

Labeler - CLT Logistics, Inc (243174344)