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NDC 21749-0027-01 PURELL Advanced Hand Sanitizer be Peaceful 0.7 mL/mL Details

PURELL Advanced Hand Sanitizer be Peaceful 0.7 mL/mL

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

Product Information

NDC	21749-0027
Product ID	21749-027_635d36a9-318e-4788-b238-4b4ac798365e
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 be Peaceful
Proprietary Name Suffix	n/a
Non-Proprietary Name	alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
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 21749-0027-01 (21749002701)

Pricing Information	N/A
NDC Package Code	21749-027-01
Billing NDC	21749002701
Package	30 mL in 1 PACKAGE (21749-027-01)
Marketing Start Date	2016-12-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 45810c51-8738-4b8a-8d8f-46b4b41dbe93 Details

Active ingredient

Ethyl alcohol 70% v/v

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin

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
Children under 6 years of age shodl be supervised when using this product

Other information

• Store below 110°F (43°C)

• May discolor certain fabrics or surfaces

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Caprylyl glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum), Blue 1 (CI 42090), Red 40 (CI 16035)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURELL ADVANCED HAND SANITIZER BE PEACEFUL

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21749-027
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:21749-027-01	30 mL in 1 PACKAGE; Type 0: Not a Combination Product	12/22/2016
2	NDC:21749-027-02	59 mL in 1 PACKAGE; Type 0: Not a Combination Product	12/22/2016
3	NDC:21749-027-04	118 mL in 1 PACKAGE; Type 0: Not a Combination Product	12/22/2016
4	NDC:21749-027-08	236 mL in 1 PACKAGE; Type 0: Not a Combination Product	12/22/2016
5	NDC:21749-027-10	295 mL in 1 PACKAGE; Type 0: Not a Combination Product	12/22/2016
6	NDC:21749-027-12	354 mL in 1 PACKAGE; Type 0: Not a Combination Product	12/22/2016
7	NDC:21749-027-45	450 mL in 1 PACKAGE; Type 0: Not a Combination Product	12/22/2016
8	NDC:21749-027-16	473 mL in 1 PACKAGE; Type 0: Not a Combination Product	12/22/2016
9	NDC:21749-027-20	591 mL in 1 PACKAGE; Type 0: Not a Combination Product	12/22/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/22/2016

Labeler - GOJO Industries, Inc. (004162038)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		036424534	manufacture(21749-027)

Revised: 12/2016

Document Id: 635d36a9-318e-4788-b238-4b4ac798365e

Set id: 45810c51-8738-4b8a-8d8f-46b4b41dbe93

Version: 2

Effective Time: 20161222