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

OTC - ACTIVE INGREDIENT

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

OTC - PURPOSE

Topical analgesic

Skin protectant

INDICATIONS & USAGE

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

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

on chicken pox
on measles

avoid contact with the eyes

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

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

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

store at 20°-25°C (68°-77°F)

INACTIVE INGREDIENT

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

OTC - QUESTIONS

1-800-616-2471

OTC - KEEP OUT OF REACH OF CHILDREN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Banophen

GENERIC: Diphenhydramine Hydrochloride, Zinc Acetate

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 61786-194-06

ACTIVE INGREDIENT(S):

DIPHENHYDRAMINE HYDROCHLORIDE 2g in 100g
ZINC ACETATE 0.1g in 100g

INACTIVE INGREDIENT(S):

CETYL ALCOHOL

PACKAGING: 28 g in 1 TUBE

OUTER PACKAGING: 1 TUBE in 1 CARTON

MM1

MM2

BANOPHEN
diphenhydramine hydrochloride, zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61786-194(NDC:0904-5354)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2 g in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CETYL ALCOHOL (UNII: 936JST6JCN)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61786-194-06	28 g in 1 TUBE; Type 0: Not a Combination Product	02/20/2015	03/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/20/2015	03/13/2017

Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2017

Document Id: 4aa6c3d9-89ca-3d8c-e054-00144ff8d46c

Set id: e79cf602-dc91-4fb9-844d-efed58e728d9

Version: 2

Effective Time: 20170313

REMEDYREPACK INC.