ALCOHOL PREP - isopropyl alcohol swab 
Dynarex 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.

----------

Sterile Alcohol Prep Pads

Active Ingredient                                       Purpose

Isopropyl Alcohol 70% v/v                         Antiseptic


Use: alcohol_prep

For preparation of the skin prior to injection.

Warnings:

  • For external use only
  • Flammable, keep away from flame or fire
  • Not for use with electrocautinary devices or procedures
  • Do not use in eyes
  • Sterile unless package is damaged or open.

Indications and Usage:

Stop use and ask a doctor if:

  • Irritation or redness develops
  • condition persists for more than 72 hours
  • Cleansing of an injection site

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions:

Wipe injection site vigorously and discard

Other information:

  • Store at room temperature: 15 deg C to 30 deg C   59 deg F to 86 deg F
  • avoid excessive heat

Inactive Ingredient

Inactive Ingredient

  • Water

Principal Display Panel

alcohol_prep

alcohol_prep




ALCOHOL PREP 
isopropyl alcohol swab
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67777-121
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-121-1420 in 1 CASE
1100 in 1 BOX
10.55 mL in 1 POUCH
2NDC:67777-121-1610 in 1 CASE
2100 in 1 BOX
20.7 mL in 1 POUCH
3NDC:67777-121-1310 in 1 CASE
3200 in 1 BOX
30.55 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/01/2010
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Shandong Haiyan Medical Manufacture Co., Ltd.421283439manufacture(67777-121)
Establishment
NameAddressID/FEIBusiness Operations
Phoenix Healthcare Solutions, LLC079146847manufacture(67777-121)

Revised: 4/2014
 
Dynarex Corporation