INSTANT ANTISEPTIC HAND SANITIZER- alcohol solution

Instant Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

Instant Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by United Laboratories Inc., Woodbine Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Ethyl Alcohol 70%v/v

Purpose

Sanitizer

Uses

For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this productavoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor ifirritation or redness develops, or if 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

Apply gel to dry hands and rub thoroughly until hands are dry. Do not rinse or wipe gel off. Should solution enter eyes, rinse immediately with water.

Other Information

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

Inactive ingredients

Water, Propylene Glycol, PEG-33 (and) PEG-8 Dimethicone (and) PEG-14, Triethanolamine, Carbopol and Fragrance.

PRINCIPAL DISPLAY PANEL - 750 ml Bottle Label

UNITED
LABORATORIES

United 364

CONTACT PLUS

Instant Antiseptic
Hand Sanitizer

Kills 99.99% of common germs that can cause
disease. Evaporates quickly.

750 ml (25 fl. oz.)

Made in USA 1018

INGREDIENTS AND APPEARANCE

INSTANT ANTISEPTIC HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63998-364
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63998-364-01	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/01/2019

Labeler - United Laboratories Inc. (001759737)

Establishment
Name	Address	ID/FEI	Business Operations
Woodbine Products Company		004220323	manufacture(63998-364)