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Name:Banophen
Manufacturer:Major Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


Major Pharmaceuticals Banophen™ Drug Facts

BANOPHEN - diphenhydramine hydrochloride and zinc acetate cream 
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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Major Pharmaceuticals Banophen™ Drug Facts

Active ingredient

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

Topical analgesic

Skin protectant

Uses

  • temporarily relieves pain and itching associated with:
  • insect bites
  • minor burns
  • sunburn
  • minor skin irritations
  • minor cuts
  • scrapes
  • rashes due to poison ivy, poison oak and poison sumac
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

For external use only

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

  • on chicken pox
  • on measles

When using this product

  • avoid contact with the eyes

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

  • do not use more than directed
  • adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Other information

  • store at 20°-25°C (68°-77°F)

Inactive ingredients

cetyl alcohol, diazolidinyl urea, methylparaben, PEG-2 stearate, PEG-20 stearate, propylene glycol, propylparaben, purified water

Questions or comments?

1-800-616-2471

Principal Display Panel

Extra Strength

Banophen™

Anti-Itch Cream

Topical Analgesic/Skin Protectant

Banophen(tm) Carton

Banophen(tm) Carton


BANOPHEN 
diphenhydramine hydrochloride, zinc acetate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5354
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 2 g  in 100 g
ZINC ACETATE (ZINC) ZINC ACETATE 0.1 g  in 100 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-5354-31 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 28 g in 1 TUBE This package is contained within the CARTON (0904-5354-31)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 06/19/2009

Labeler - Major Pharmaceuticals (191427277)

Revised: 05/2009 Major Pharmaceuticals



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


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