SPECTRUM HAND SANITIZER- ethyl alcohol gel

Spectrum Hand Sanitizer by

Drug Labeling and Warnings

Spectrum Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

• Ethyl alcohol 85%

PURPOSE

Purpose

• Antiseptic

INDICATIONS & USAGE

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

WARNINGS

Warnings
For external use only: hands

Flammable. Keep away from heat
and flame.

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

STOP USE

Stop use and ask a doctor if
■ irritation or redness develops
■ condition persists for more than
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
right away.

SPL UNCLASSIFIED SECTION

*Effective at eliminating 99.9999% of
many common harmful germs and
bacteria on average in 15 seconds.

DOSAGE & ADMINISTRATION

Directions ■ wet hands thoroughly with product and
allow to dry without wiping
■ for children under 6, use only
under adult supervision

OTHER SAFETY INFORMATION

Other information
■ do not store above 105 degrees F
■ may discolor some fabrics
■ harmful to wood finishes and
plastics

INACTIVE INGREDIENT

Inactive ingredients
Acrylates/C10-30 alkyl acrylate
crosspolymer, bisabolol,
cyclomethicone, glycerin,
isohexadecane, myristyl alcohol,
povidone, tetrahydroxypropyl
ethylenediamine, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPECTRUM HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	85 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LEVOMENOL (UNII: 24WE03BX2T)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POVIDONE (UNII: FZ989GH94E)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
CYCLOMETHICONE (UNII: NMQ347994Z)
ISOHEXADECANE (UNII: 918X1OUF1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-003-14	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2018
2	NDC: 53329-003-70	443 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2018
3	NDC: 53329-003-84	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/06/2018

Labeler - Medline Industries (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc.		088520668	manufacture(53329-003)