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NDC 21749-0022-02 PURELL Advanced Hand Sanitizer Biobased Content 0.7 mL/mL Details

PURELL Advanced Hand Sanitizer Biobased Content 0.7 mL/mL

PURELL Advanced Hand Sanitizer Biobased Content is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by GOJO Industries, Inc.. The primary component is ALCOHOL.

Product Information

NDC	21749-0022
Product ID	21749-022_ee69d167-3e98-4708-a1c1-ba5aeb198a9b
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	PURELL Advanced Hand Sanitizer Biobased Content
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.7
Active Ingredient Units	mL/mL
Substance Name	ALCOHOL
Labeler Name	GOJO Industries, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 21749-0022-02 (21749002202)

Pricing Information	N/A
NDC Package Code	21749-022-02
Billing NDC	21749002202
Package	60 mL in 1 BOTTLE (21749-022-02)
Marketing Start Date	2017-04-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 60584888-a800-4825-85b3-cf55ca7c045e Details

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease
Recommended for repeated use

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product in your palm to thoroughly cover your hands
Rub hands together briskly until dry
No rinsing required
No towels needed

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURELL ADVANCED HAND SANITIZER BIOBASED CONTENT

alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21749-022
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.70 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Isopropyl Alcohol (UNII: ND2M416302)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
Caprylyl Glycol (UNII: 00YIU5438U)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:21749-022-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2017
2	NDC:21749-022-03	88 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2017
3	NDC:21749-022-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2017
4	NDC:21749-022-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2017
5	NDC:21749-022-20	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/15/2017

Labeler - GOJO Industries, Inc. (004162038)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		036424534	manufacture(21749-022)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		088312414	manufacture(21749-022) , label(21749-022) , pack(21749-022)

Name	Address	ID/FEI	Business Operations
Establishment
Travis Association for the Blind		026032268	label(21749-022) , pack(21749-022)

Revised: 4/2017

Document Id: ee69d167-3e98-4708-a1c1-ba5aeb198a9b

Set id: 60584888-a800-4825-85b3-cf55ca7c045e

Version: 1

Effective Time: 20170415