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NDC 11084-0813-80 Soft N Sure Foamed Antiseptic Handrub 62 g/100g Details

Soft N Sure Foamed Antiseptic Handrub 62 g/100g

Soft N Sure Foamed Antiseptic Handrub is a TOPICAL AEROSOL, FOAM in the HUMAN OTC DRUG category. It is labeled and distributed by SC Johnson Professional USA, Inc.. The primary component is ALCOHOL.

Product Information

NDC	11084-0813
Product ID	11084-813_c191d5a9-f197-46c0-8308-aaef0a131413
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	Soft N Sure Foamed Antiseptic Handrub
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	AEROSOL, FOAM
Route	TOPICAL
Active Ingredient Strength	62
Active Ingredient Units	g/100g
Substance Name	ALCOHOL
Labeler Name	SC Johnson Professional USA, 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 11084-0813-80 (11084081380)

Pricing Information	N/A
NDC Package Code	11084-813-80
Billing NDC	11084081380
Package	482 g in 1 CAN (11084-813-80)
Marketing Start Date	2018-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d8947a0c-21b3-4fe4-a1a3-620e64cdf889 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Ethyl Alcohol 62% v/v

Purpose

Antiseptic

Uses

Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatment.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

When using this product

avoid contact with eyes. If splashed in eyes, rinse promptly and thoroughly with water
do not puncture or incinerate; contents under pressure.

Stop use and ask a doctor if

irritation and redness develop. If irritation persists for more than 3 days, consult a physician.

Keep out of reach children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Healthcare Personnel Handwash Apply product to hands and rub until thoroughly dry

Other information

Do not store above 120°F (49°C). For best foam density store and use at 55 - 85°F (13 - 29°C).

Inactive ingredients

Aqua (Water), Emulsifying Wax, Hydrofluorocarbon 152A, Isobutane, Propane.

Questions or comments?

1-866-783-0422

PRINCIPAL DISPLAY PANEL - 255 g Can Label

SCJ PROFESSIONAL

HEALTHCARE

Soft 'N Sure®

NDC 11084-813-36

Hand Sanitizer

Foamed Antiseptic Handrub

Moisturization

15

seconds

Fast Acting

CHG Compatible

Net Weight: 255 g (9 oz)

SAP # 4000000054

Manufactured for:

SC Johnson Professional USA, Inc.

Charlotte, NC 28217

1-866-783-0422 www.scjp.com

Pat. www.scjp.com/patents

REORDER #

1381-36

deb

SKIN CARE

PRINCIPAL DISPLAY PANEL - 255 g Can Label

INGREDIENTS AND APPEARANCE

SOFT N SURE FOAMED ANTISEPTIC HANDRUB

alcohol aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11084-813
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)
ISOBUTANE (UNII: BXR49TP611)
PROPANE (UNII: T75W9911L6)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11084-813-80	482 g in 1 CAN; Type 0: Not a Combination Product	02/01/2018
2	NDC:11084-813-36	255 g in 1 CAN; Type 0: Not a Combination Product	02/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/01/2018

Labeler - SC Johnson Professional USA, Inc. (607378015)

Name	Address	ID/FEI	Business Operations
Establishment
Accra Pac, Inc.		024213616	MANUFACTURE(11084-813)

Revised: 12/2020

Document Id: c191d5a9-f197-46c0-8308-aaef0a131413

Set id: d8947a0c-21b3-4fe4-a1a3-620e64cdf889

Version: 2

Effective Time: 20201204