Alcohol Prep Pads

Drug Labeling and Warnings

Drug Details [pdf]

ALCOHOL PREP- isopropyl alcohol swab 
Major Pharmaceuticals

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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Alcohol Prep Pads

Active Ingredient                                       Purpose

Isopropyl Alcohol 70% v/v                         Antiseptic


Use:alcohol prep pads

Antiseptic cleanser for preparation of the skin prior to injection.

Warnings:

  • For external use only
  • Flammable, keep away from flame or fire

Indications and Usage:


  • Topical cleansing and preparation of skin prior to  injection.

Keep out of reach of children.

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

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

Do Not Use

  • With electrocautery procedures
  • in the eyes

Stop use and ask a doctor if:

  • irritation and redness develops
  • if condition persists for more than 72 hours, consult a physician.

Principal Display Panel

Alcohol Prep Pad

Major_Alcohol_Prep_Pads


ALCOHOL PREP 
isopropyl alcohol swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0904-6245
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL1.4 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0904-6245-6010 in 1 CASE04/21/2011
1100 in 1 BOX; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/21/201108/20/2019
Labeler - Major Pharmaceuticals (191427277)

Revised: 8/2019
Document Id: 90924340-0ac5-0d21-e053-2995a90acd3e
Set id: 46638f64-3e7b-45ca-b8cb-7a1928f5ba6b
Version: 5
Effective Time: 20190820
 
Major Pharmaceuticals