BANOPHEN- diphenhydramine hydrochloride, 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 ITCH RELIEF

COMPARE TO Active Ingredients Of EXTRA STRENGTH BENADRYL® CREAM

EXTRA STRENGTH

Banophen™

Relieves Itches From Insect Bites And Skin Irritations

EXTRA STRENGTH

Banophen™

Anti-Itch Cream

Topical Analgesic / Skin Protectant

NET WT 1 OZ (28 g)

622-5c-banophen-1
622-5c-banophen-2
BANOPHEN 
diphenhydramine hydrochloride, zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5354
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PEG-2 STEARATE (UNII: 94YQ11Y95F)  
PEG-20 STEARATE (UNII: NBX892EA57)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5354-311 in 1 CARTON06/19/2009
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/19/2009
Labeler - Major Pharmaceuticals (191427277)

Revised: 7/2020
Document Id: fea40969-7f10-4f6a-b4e7-8afa9d24e661
Set id: 9758d886-bd58-4eb2-a827-fa8e7fee2b7c
Version: 3
Effective Time: 20200728
 
Major Pharmaceuticals