Major Pharmaceuticals Banophen™ Drug Facts

Major Pharmaceuticals Banophen™ Drug Facts
SPL v5
SPL
SPL Set ID 9758d886-bd58-4eb2-a827-fa8e7fee2b7c
Route
TOPICAL
Published
Effective Date 2026-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (2 g) Zinc Cation (0.1 g)
Inactive Ingredients
Cetyl Alcohol Diazolidinyl Urea Methylparaben Diethylene Glycol Mono- And Dipalmitostearate Peg-20 Stearate Propylene Glycol Propylparaben Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-06-19

Description

Diphenhydramine hydrochloride 2% Zinc acetate 0.1%

Purpose

Topical analgesic Skin protectant


Medication Information

Purpose

Topical analgesic

Skin protectant

Description

Diphenhydramine hydrochloride 2% Zinc acetate 0.1%

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

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
Do Not Use
  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Other Information
  • store at 20°-25°C (68°-77°F)
Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Inactive Ingredients

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

Questions Or Comments?

1-800-719-9260

Ask A Doctor Before Use
  • on chicken pox
  • on measles
Principal Display Panel

MAJOR®

compare to the active ingredients in Extra Strength Benadryl® Itch Stopping Cream

extra strength

banophen™

diphenhydramine HCl 2%

zinc acetate 0.1%

anti-itch cream

topical analgesic skin protectant

net wt 1 oz (28 g)

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. (1-800-222-1222)


Structured Label Content

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
Purpose

Topical analgesic

Skin protectant

Warnings

For external use only

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
Do Not Use (Do not use)
  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Other Information (Other information)
  • store at 20°-25°C (68°-77°F)
Active Ingredients (Active ingredients)

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Ask A Doctor Before Use (Ask a doctor before use)
  • on chicken pox
  • on measles
Principal Display Panel

MAJOR®

compare to the active ingredients in Extra Strength Benadryl® Itch Stopping Cream

extra strength

banophen™

diphenhydramine HCl 2%

zinc acetate 0.1%

anti-itch cream

topical analgesic skin protectant

net wt 1 oz (28 g)

When Using This Product (When using this product)
  • avoid contact with the eyes
Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Advanced Ingredient Data


Raw Label Data

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