ALCOHOL BASED HAND SANITIZER- alcohol gel
Market Derma Research dba Protex Labs

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Alcohol Based Hand Sanitizer Gel

Drug Facts

Active ingredient

Ethyl alcohol 70% v/V

Purpose

Antimicrobial

Use

• Hand sanitizer to help reduce bacteria on the skin

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product

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

Stop use and ask a doctor

if irritation or rash appears and lasts

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 this product

Other information

• Store below 110°F (43°C)
• May discolor certain fabrics or surfaces

Inactive ingredients

Water, Aloe Vera Extract (Aloe Barbadensis), Carbomer, Glycerin, Tocopheryl Acetate,

Package Labeling

Bottle

ALCOHOL BASED HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77792-000
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77792-000-00	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/01/2020

Labeler - Market Derma Research dba Protex Labs (024520891)