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Name:Alcohol Prep Pad With Benzocaine
Manufacturer:Major Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

ALCOHOL PREP PAD WITH BENZOCAINE  - benzocaine and 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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DRUG FACTS

ACTIVE INGREDIENTS

Benzocaine 6%
Isopropyl alcohol 70% v/v

PURPOSE

Topical Anesthetic

Antiseptic

USES

  • For preparation of the skin prior to injection
  • For temporary relief of pain and itching associated with minor burns, sunburn, minor skin irritations, or insect bites

WARNINGS

For external use only.

Flammable, keep away from fire or flame.

Do not use

  • in the eyes
  • with electrocautery procedures




Stop use and ask a doctor

  • if irritation and redness develop
  • if symptoms persist for more than 72 hours or symptoms clear up and occur within a few days.


Ask a doctor or pharmacist

if you are pregnant or nursing a baby.

Keep out of reach of children

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

DIRECTIONS

Prior to Injection - Adults and children 2 years of age or older:
Apply to the skin just prior to injection. Benzocaine takes a minute to act. for best results, wait briefly and then make injection.

Insect bites, skin irritations, minor burns, sunburn -
Adults and children 2 years of age or older:

Apply to the affected site not more than 3 to 4 times daily.

Children under 2 years of age: Ask a doctor.


OTHER INFORMATION

  • Store at room temperature: 15° - 30° C (59° - 86° F)
  • Do not use to clean and disinfect medical devices or on hard surfaces.

INACTIVE INGREDIENTS

propylene glycol, purified water


CARTON INFORMATION

MAJOR                        NDC 0904-5836-47

Alcohol Prep Pads
with Benzocaine for Pain Relief

Antiseptic / Anesthetic
Isopropyl Alcohol 70%
Safe and easy to use

80 Individually Wrapped Pads

Distributed by:
Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150 USA

To report adverse drug events call: 800-616-2471

CARTON


ALCOHOL PREP PAD WITH BENZOCAINE 
benzocaine swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5836
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
benzocaine (benzocaine) benzocaine 0.06 mL
isopropyl alcohol (isopropyl alcohol) isopropyl alcohol 0.70 mL
Inactive Ingredients
Ingredient Name Strength
propylene glycol  
water  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-5836-47 80 PACKET ( PACKET) in 1 CARTON contains a PACKET
1 1 SWAB ( SWAB) in 1 PACKET This package is contained within the CARTON (0904-5836-47)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 04/01/2008

Labeler - Major Pharmaceuticals (191427277)

Revised: 12/2009 Major Pharmaceuticals



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


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