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NDC 21749-0992-89 PURELL Waterless Surgical Scrub 0.7 mL/mL Details

PURELL Waterless Surgical Scrub 0.7 mL/mL

PURELL Waterless Surgical Scrub 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	21749-0992
Product ID	21749-992_fbeebc0d-12ed-4beb-89d5-c6389398d088
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 Waterless Surgical Scrub
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 21749-0992-89 (21749099289)

Pricing Information	N/A
NDC Package Code	21749-992-89
Billing NDC	21749099289
Package	1200 mL in 1 BOTTLE (21749-992-89)
Marketing Start Date	2011-12-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e3ed5e0c-1e21-47eb-a999-9c8aa5083dff Details

Active ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic surgical hand scrub

Uses

Significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care

Warnings

Flammable. Keep away from fire or flame.

For external use only

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase the risk of sunburn. Take steps to limit sun exposure while using this product and for one week following use.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist 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

clean under the nails with a nail pick
mails should be maintained with a 1 millimeter free edge
place 2 mL of product into palm of one hand
dip fingers of opposite hand into the product and work under nails
spread remaining product evenly over the hands and lower 2/3 of one forearm paying particular attention to the nails, cuticles, and interdigital spaces
place 2 mL of product into opposite hand and repeat steps above
allow to air dry completely

Inactive ingredients

Water (Aqua), Isopropyl Myristate, Glycerin, Diisopropyl Sebacate, Citric Acid, PEG/PPG-20/6 Dimethicone, Tetradibutyl Pentaerythrityl Hydroxyhydrocinnamate, Hydroxypropylcellulose, Polyquaternium-37, Methylchloroisothiazolinone, Methylisothiazolinone

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURELL WATERLESS SURGICAL SCRUB

alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21749-992
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)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:21749-992-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2011
2	NDC:21749-992-33	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2011
3	NDC:21749-992-89	1200 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/15/2011

Labeler - GOJO Industries, Inc. (004162038)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		036424534	MANUFACTURE(21749-992)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		088312414	MANUFACTURE(21749-992) , label(21749-992) , pack(21749-992)

Revised: 10/2017

Document Id: fbeebc0d-12ed-4beb-89d5-c6389398d088

Set id: e3ed5e0c-1e21-47eb-a999-9c8aa5083dff

Version: 3

Effective Time: 20171002