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NDC 63998-0364-01 Instant Antiseptic Hand Sanitizer 70 mL/100mL Details

Instant Antiseptic Hand Sanitizer 70 mL/100mL

Instant Antiseptic Hand Sanitizer is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by United Laboratories Inc.. The primary component is ALCOHOL.

Product Information

NDC	63998-0364
Product ID	63998-364_91e54780-0948-4b73-86dc-573b02d4b78d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Instant Antiseptic Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	United Laboratories Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63998-0364-01 (63998036401)

Pricing Information	N/A
NDC Package Code	63998-364-01
Billing NDC	63998036401
Package	750 mL in 1 BOTTLE (63998-364-01)
Marketing Start Date	2019-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f91a5ac5-0f78-4cf5-be57-6562714791cd Details

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 product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation 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

PRINCIPAL DISPLAY PANEL - 750 ml Bottle Label

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part333A	01/01/2019

Labeler - United Laboratories Inc. (001759737)

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

Revised: 11/2020

Document Id: 91e54780-0948-4b73-86dc-573b02d4b78d

Set id: f91a5ac5-0f78-4cf5-be57-6562714791cd

Version: 1

Effective Time: 20201109