ACTIPREP PREOPERATIVE SKIN PREPARATION

Dosage form: lotion
Ingredients: ALCOHOL 0.79mL in 1mL
Labeler: HEALTHPOINT, LTD
NDC Code: 0064-1011

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.

ACTIPREP® PREOPERATIVE SKIN PREPARATION – alcohol lotion

Drug Facts

Active Ingredient

Ethyl Alcohol 73% w/w

Purpose

Antiseptic

Uses
  • For the preparation of the skin prior to surgery or an injection.
  • Helps reduce bacteria that potentially can cause skin infection.

Warnings
  • Flammable, keep away from fire or flame.
  • For external use on intact skin only.
  • Do not allow product to pool or run.
  • Do not drape or use ignition source (e.g., electrosurgery unit) until dry for 2-3 minutes on the skin.
  • If prep gets in hair, allow to dry completely.
  • To reduce potential for irritation, caution should be used to avoid the axilla and genital areas.

Do Not Use
  • on open skin wounds or as a general cleanser
  • near eyes or mouth
  • in non-ventilated areas
  • on mucous membrane tissue

When using this product, keep out of eyes and mouth.  If contact occurs, immediately wash with cold water and contact physician.

Stop use and ask physician if irritation, sensitization, or allergic reaction occurs.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  1. Clean the area. Shake well and apply ACTIPREP® with a sterile sponge or gauze to the operative site.
  2. Paint site from the center and work outward (do not go back to center). Do not scrub.
    Paint one uniform, thin application.
  3. If pooling occurs during application, blot excess and continue to apply one uniform application.
  4. Once a uniform application is applied, allow preoperative site to completely dry (approximately 2-3 minutes) before draping.
  5. Check for pooling and fluid-soaked articles on or under the patient.  Remove and replace the wet articles.  Properly discard after use.

Other Information

  • Store at 20-25° C (68-77° F).
  • Avoid freezing and excessive heat above 40° C (104° F).
  • Do not drape or use ignition source (e.g., electrosurgery unit) until dry for 2-3 minutes on the skin.

Inactive Ingredient

Ascorbyl Palmitate, Benzyl Alcohol, Citric Acid Monohydrate, D&C Orange #4, Fragrance, Glyceryl Laurate, Hydroxypropylcellulose, Isopropyl Myristate, Linoleic Acid, Phenylethyl Alcohol, Polyoxyl 40 Stearate, Povidone, Propylene Glycol, Purified Water, Zinc Pyrithione.

Questions?

Call 1-800-441-8227 or visit our web site www.healthpoint.com.

Marketed by:
Healthpoint, Ltd.
Fort Worth, Texas 76107
1-800-441-8227
www.healthpoint.com
REORDER NO. 0064-1011-16
PATENT NO. 6,110,908

128324-0206

PPRINCIPAL DISPLAY PANEL

NDC 0064-1011-16

ACTIPREP®

ANTISEPTIC

PREOPERATIVE SKIN PREPARATION

  • Fast-Acting
  • Broad Spectrum
  • Persistent

CHG and Iodine Free

16 FL OZ (473 mL)

ACTIPREP  PREOPERATIVE SKIN PREPARATION
ethyl alcohol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0064-1011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL0.79 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ASCORBYL PALMITATE 
BENZYL ALCOHOL 
CITRIC ACID MONOHYDRATE 
D&C ORANGE NO. 4 
GLYCERYL LAURATE 
HYDROXYPROPYL CELLULOSE 
ISOPROPYL MYRISTATE 
LINOLEIC ACID 
PHENETHYL ALCOHOL 
POLYOXYL 40 STEARATE 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
PYRITHIONE ZINC 
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0064-1011-0259 mL in 1 BOTTLE, PLASTIC
2NDC:0064-1011-16473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/01/2001
Labeler - HEALTHPOINT, LTD (965634504)
Establishment
NameAddressID/FEIOperations
DPT LABORATORIES, LTD832224526MANUFACTURE

Revised: 11/2010
 
HEALTHPOINT, LTD

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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