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Name:Alcohol
Manufacturer:American Sales Company, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ALCOHOL - isopropyl alcohol swab 
American Sales Company, Inc.

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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Drug Facts

Active ingredient

Isopropyl Alcohol, 70% v/v

Purpose

Antiseptic

Uses

  • For preparation of the skin prior to injection.
  • First aid to decrease germs in minor cuts, scrapes and burns.

Warnings

  • For external use only.
  • Flammable. Keep away from fire or flame.

Do not use

  • with electrocautery procedures
  • longer than 1 week unless directed by a doctor

When using this product

  • do not get into eyes
  • do not apply over large areas of the body
  • in case of deep or puncture wounds, animal bites or serious burns, consult a doctor
  • use only in a well ventilated area; fumes may be toxic

Stop use and ask a doctor if

  • irritation and redness develop
  • condition gets worse or persists for more than 72 hours

Keep out of reach of children.

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

Directions

  • Apply to skin as needed
  • Discard after single use

Other information

Protect from freezing and avoid excessive heat.

Inactive Ingredients

Water

Principal Display Panel

 CareOne Alcohol Swab box front, side, bottom

CareOne

Compare to BD Active Ingredient

Individually Foil Wrapped

DO NOT USE IF PRODUCT IS TORN OR PUNCTURED

ALCOHOL SWABS

70% ISOPROPYL ALCOHOL

  • 2-Ply Pad Offers Excellent Cleansing Action
  • Antiseptic for Preparation of the Skin Prior to Injection

100 SWABS

Principal Display Panel

CareOne Alcohol Swab box top, back, side, bottom

CareOne Alcohol Swab box top, back, side, bottom


ALCOHOL 
isopropyl alcohol swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-809
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 70 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41520-809-30 100 PACKET ( PACKET) in 1 BOX contains a PACKET
1 1 APPLICATOR ( APPLICATOR) in 1 PACKET This package is contained within the BOX (41520-809-30) and contains a APPLICATOR
1 0.5 mL in 1 APPLICATOR This package is contained within a PACKET and a BOX (41520-809-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/08/2011

Labeler - American Sales Company, Inc. (809183973)

Revised: 04/2011 American Sales Company, Inc.



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


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