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Name:Alcohol
Manufacturer:Fred's Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ALCOHOL - isopropyl alcohol swab 
Fred's 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

Warnings

For external use only.

When using this product

  • Do not get into eyes
  • apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a doctor.

Stop use and ask a doctor if

  • condition persists or gets worse or lasts for more than 72 hours
  • do not use longer than 1 week unless directed by a doctor

Flammable

  • Keep away from fire or flame
  • Do not use with electrocautery procedures
  • Use only in a well-ventilated area, fumes may be toxic

Keep out of reach of children.

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

Directions

Wipe injection site vigorously. Discard after single use.

Other information

Protect from freezing and avoid excessive heat.

Inactive ingredients

Water

Package/Label Principal Display Panel

Fred's Alcohol Swabs box -  Front, Side, Bottom

FRED'S

Alcohol Swabs

Antiseptic for preparation of the skin prior to injection

Thicker, Softer

  • Individually Foil Wrapped
  • 70% Isopropyl Alcohol

100 SWABS

Package/Label Back

Fred's Alcohol Swabs box -  Top, Side, Bottom, Back

Fred's Alcohol Swabs Box Top, Back, Side, Bottom


ALCOHOL 
isopropyl alcohol swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-809
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:55315-809-30 100 PACKET ( PACKET) in 1 BOX contains a PACKET
1 1 APPLICATOR ( APPLICATOR) in 1 PACKET This package is contained within the BOX (55315-809-30) and contains a APPLICATOR
1 5 mL in 1 APPLICATOR This package is contained within a PACKET and a BOX (55315-809-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/05/2011

Labeler - Fred's Inc. (005866116)

Revised: 04/2011 Fred's Inc.



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


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