BENADRYL EXTRA STRENGTH ITCH COOLING- diphenhydramine hydrochloride and zinc acetate spray 
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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BENADRYL EXTRA STRENGTH ITCH COOLING SPRAY

REQUIRED INFORMATION

Drug Facts

Active ingredientsPurpose
Diphenhydramine HCl 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.

Flammable. Keep away from fire or flame.

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: spray on affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Other information

  • store at 20° to 25°C (68° to 77° F)

Inactive ingredients

alcohol, glycerin, PVP, purified water, tromethamine

Questions?

call 1-800-524-2624 (English/Spanish)

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

EXTRA STRENGTH
Benadryl®
Topical Analgesic/Skin Protectant
ITCH COOLING SPRAY

Relief for most
outdoor itches

Insect
Bites

Poison Ivy,
Oak, Sumac

Mosquito
Bites

Sunburn

Minor Cuts
& Scrapes

2 FL OZ (59 mL)

Principal Display Panel - 59 mL Bottle Label
BENADRYL EXTRA STRENGTH ITCH COOLING 
diphenhydramine hydrochloride and zinc acetate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-0750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride20 mg  in 1 mL
Zinc Acetate (UNII: FM5526K07A) (Zinc Cation - UNII:13S1S8SF37) Zinc Acetate1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Glycerin (UNII: PDC6A3C0OX)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Water (UNII: 059QF0KO0R)  
Tromethamine (UNII: 023C2WHX2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58232-0750-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/01/201205/29/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34804/01/201205/29/2021
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 9/2020
Document Id: ebf60b5a-68cb-44a4-bed5-4b0d13f43b55
Set id: 9c103aa1-6994-4aed-9907-c11103e5b1ba
Version: 5
Effective Time: 20200922
 
Johnson & Johnson Consumer Inc.