BENADRYL EXTRA STRENGTH  ITCH STOPPING- diphenhydramine hydrochloride and zinc acetate cream 
Johnson & Johnson Consumer 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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Extra Strength
BENADRYL ITCH STOPPING CREAM

Drug Facts

Active ingredientsPurpose
Diphenhydramine hydrochloride 2%Topical analgesic
Zinc acetate 0.1%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 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 not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Other information

  • protect from excessive heat (40°C/104°F)

Inactive ingredients

cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, purified water

Questions?

call toll-free 800-524-2624 (English/Spanish) or 215-273-8755 (collect)

Dist: Johnson & Johnson Consumer Products Company
Division of Johnson & Johnson Consumer Companies Inc.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 28.3g Tube Carton

EXTRA STRENGTH

Benadryl®

Topical Analgesic/Skin Protectant

ITCH
STOPPING
CREAM

NET WT 1 OZ (28.3g)

PRINCIPAL DISPLAY PANEL - 28.3g Tube Carton
BENADRYL EXTRA STRENGTH   ITCH STOPPING
diphenhydramine hydrochloride and zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-0741
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride20 mg  in 1 g
Zinc Acetate (UNII: FM5526K07A) (Zinc Cation - UNII:13S1S8SF37) Zinc Acetate1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Cetyl Alcohol (UNII: 936JST6JCN)  
Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Propylparaben (UNII: Z8IX2SC1OH)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58232-0741-11 in 1 CARTON10/15/201209/01/2018
128.3 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:58232-0741-21 in 1 CARTON10/15/201209/01/2018
236.9 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 finalpart34810/15/201209/01/2018
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 8/2016
Document Id: 1794d47e-6dff-4a9d-9f71-3ff4e0202a7c
Set id: 2a5ea2a6-7973-4a40-8c76-626eb9ac6155
Version: 4
Effective Time: 20160826
 
Johnson & Johnson Consumer Inc.