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Name:Actipreppreoperative Skin Preparation
Manufacturer:Healthpoint, Ltd
Category:Over-the-counter (OTC) Marketed Drugs


ACTIPREP® PREOPERATIVE SKIN PREPARATION – alcohol lotion

ACTIPREP PREOPERATIVE SKIN PREPARATION - alcohol lotion 
HEALTHPOINT, LTD

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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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)

2c0306c4-figure-01

ACTIPREP  PREOPERATIVE SKIN PREPARATION
ethyl alcohol lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0064-1011
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.79 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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
Color ORANGE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0064-1011-02 59 mL in 1 BOTTLE, PLASTIC None
2 NDC:0064-1011-16 473 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 10/01/2001

Labeler - HEALTHPOINT, LTD (965634504)
Establishment
Name Address ID/FEI Operations
DPT LABORATORIES, LTD 832224526 MANUFACTURE

Revised: 11/2010 HEALTHPOINT, LTD



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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