HAND SANITIZER- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Medline Industries, Inc., Vi-Jon, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

• To decrease bacteria on the skin that could potentially cause disease
• recommended for repeated use.

Warnings

For external use only: hands

Flammable, keep away from fire or flame.

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.

Stop use and ask a doctor if

• irritation or redness develop
• condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wet hands thoroughly with product and allow to dry without wiping
• For children under 6, use only under adult supervision
• Not recommended for infants.

Other Information

• Do not store above 105 F
• May discolor some fabrics
• Harmful to wood finishes and plastics

Inactive ingredients

Water, aloe barbadensis leaf juice, tocopheryl acetate, glycerin, carbomer, propylene glycol, isopropyl myristate

Package/Label Principal Display Panel

MEDLINE

NDC: 53329-201-70

HAND SANITIZER GEL

62% ETHYL ALCOHOL

Fragrance Free

15 FL OZ 443 mL

REF HH62G15

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-201
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
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-201-13	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2015
2	NDC: 53329-201-70	443 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2015
3	NDC: 53329-201-84	1000 mL in 1 BAG; Type 0: Not a Combination Product	04/06/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/06/2015

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		088520668	manufacture(53329-201)