Soft 'N Sure® Antiseptic Hand Gel

Soft N Sure Antiseptic by

Drug Labeling and Warnings

Soft N Sure Antiseptic by is a Otc medication manufactured, distributed, or labeled by STERIS Corporation, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SOFT N SURE ANTISEPTIC- alcohol gel 
STERIS Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Soft 'N Sure® Antiseptic Hand Gel

Drug Facts

Active ingredient

Ethyl alcohol 65%

Purpose

Antiseptic

Use

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

Warnings

For external use only–hands

Flammable. Keep away from heat and flame

When using this product

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water
  • avoid contact with broken skin
  • do not inhale or ingest

Stop use and ask a doctor if skin irritation develops. If condition persists more than 72 hours consult a doctor.

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

Directions

  • wet hands thoroughly with product and allow to dry without wiping

Other information

  • do not store above 105°F
  • may discolor some fabrics
  • harmful to wood finishes and plastics

Inactive ingredients

benzophenone-4, carbomer, fragrance, glycerin, isopropyl myristate, propylene glycol, tocopheryl acetate, water

Questions or Comments?

800-548-4873

PRINCIPAL DISPLAY PANEL - 444 mL Bottle Label

Soft 'N Sure®

Antiseptic
Hand Gel

NDC: 0519-1440-13

Hand Sanitizer

Moisturizing

15
seconds
Fast-acting*

REORDER #
1445-A6

For Hospital and Professional Use Only.

Net Contents: 444mL (15 fl oz)

STERIS®

Manufactured for:
STERIS Corporation
7501 Page Avenue
St. Louis, MO 63133 ■ USA
800-548-4873 www.steris.com

61846
1445-XEG(F)(1013)
L0004254FB
Made in the USA with US
and foreign components

Principal Display Panel - 444 mL Bottle Label
SOFT N SURE ANTISEPTIC 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0519-1440
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Propylene Glycol (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
Water (UNII: 059QF0KO0R)  
SULISOBENZONE (UNII: 1W6L629B4K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0519-1440-8712 in 1 CASE03/16/201112/10/2019
1NDC: 0519-1440-411000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC: 0519-1440-936 in 1 CASE03/16/201112/10/2019
2NDC: 0519-1440-13444 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC: 0519-1440-736 in 1 CASE03/16/201112/10/2019
3NDC: 0519-1440-21946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC: 0519-1440-9248 in 1 CASE03/16/201112/10/2019
4NDC: 0519-1440-2559 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E03/16/201112/10/2019
Labeler - STERIS Corporation (139424188)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon088520668MANUFACTURE(0519-1440)

Revised: 12/2019
Document Id: 566a5299-e6a6-4bb4-a950-c197128b3a8a
Set id: 7ddc145f-2166-43e6-b981-72d3e902d221
Version: 3
Effective Time: 20191213
 
STERIS Corporation