Alcohol Prep by Medical Speciaties Distributors, LLC / Dynarex Corporation Sterile Alcohol Prep Pad

Alcohol Prep by

Drug Labeling and Warnings

Alcohol Prep by is a Otc medication manufactured, distributed, or labeled by Medical Speciaties Distributors, LLC, Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALCOHOL PREP- isopropyl alcohol swab 
Medical Speciaties Distributors, LLC

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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Sterile Alcohol Prep Pad

Active Ingredient

Isopropyl Alcohol 70% v/v                      

Purpose

Antiseptic

Uses

  • Antiseptic Cleanser
  • Kills harmful bacteria and germs
  • First aid to prevent infection

Warnings:

  • For external use only
  • Avoid contact with eys. If contact occurs flush eyes with water.
  • Flammable, keep away from flame or fire

Do not use

  • With electrcautery procedures
  • In the eyes

Stop use and ask a doctor if

  • irritation and redness develops
  • If cndition persists for more than 72 hours, consult a physician

Discontinue use and consult a healthcare practitioner if

  • irritation develops

Keep out of reach of children.

In swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • Use as part of your daily cleansing routine
  • May be covered with a sterile bandage

Other information:

  • Store at room temperature: 15° - 30° C (59° - 86° F)
  • avoid excessive heat

Inactive Ingredient

  • Water

Principal Display Panel

NDC: 62366-124-01

VersaPro TM

Sterile Alcohol Prep Pads

200 pads

  • Apply topically as needed
  • Discard after single use
  • Sterile unless pouch is open or damaged

Medium Reorder # MS341113

Label

ALCOHOL PREP 
isopropyl alcohol swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62366-124
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62366-124-011.4 mL in 1 PACKET; Type 0: Not a Combination Product01/13/201403/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/13/201403/19/2020
Labeler - Medical Speciaties Distributors, LLC (153608369)
Registrant - Phoenix Innovative Healthcare Manufacturers Private Limited (650687176)
Establishment
NameAddressID/FEIBusiness Operations
Phoenix Innovative Healthcare Manufacturers Private Limited650687176manufacture(62366-124)

Revised: 3/2020
Document Id: a13c33fb-5718-47c3-e053-2995a90a0bf9
Set id: 7041fcf8-3d65-47ed-b3ee-aaaaffa1ac55
Version: 3
Effective Time: 20200319
 
Medical Speciaties Distributors, LLC