HAND SANITIZER- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient:
Ethyl alcohol 62%

PURPOSE

Purpose

Antiseptic

WARNINGS

Warnings

For external use only: hands

Flammable. Keep away from heat and flame.

STOP USE

Stop use and ask a doctor if

• irritation or redness develops
• condition persists for more that 72 hours

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.

DOSAGE & ADMINISTRATION

Directions

• wet hands thoroughly with product and allow to dry without wiping
• for children under 6, ues only under adult supervision
• not recommended for infants

INACTIVE INGREDIENT

Inactive ingredients

acrylates/C10-C30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, glycerin, maltodextrin, propylene glycol, triethanolamine, water

OTHER SAFETY INFORMATION

Other Information

• do not store above 105F
• may discolor some fabrics
• harmful to wood finishes and plastics

INDICATIONS & USAGE

Uses to decrease bacteria on the skin that could cause disease. recommended for repeated use

WHEN USING

When using this product

• keep out of eyes. In case of contact with eyes, flush thoroughly with water.
• avoid contact with broken skin
• do not inhale or ingest

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71927-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71927-005-01	44 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/07/2019

Labeler - Orazen Inc (080916640)