Extra Strength BENADRYL Itch Cooling

Dosage form: spray
Ingredients: Diphenhydramine Hydrochloride 20mg in 1mL, Zinc Acetate 1mg in 1mL
Labeler: Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.
NDC Code: 58232-0750

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.

Extra Strength BENADRYL Itch Cooling Spray

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.

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, povidone, purified water, tromethamine

Questions?

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

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

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

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

Fast relief for most
outdoor itches

Insect
Bites

Poison Ivy,
Oak, Sumac

Mosquito
Bites

Sunburn

Minor Cuts
& Scrapes

2 FL OZ (59 mL)

EXTRA STRENGTH BENADRYL ITCH COOLING 
diphenhydramine hydrochloride and zinc acetate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-0750
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride20 mg  in 1 mL
Zinc Acetate (Zinc) Zinc Acetate1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Glycerin 
Povidone 
Water 
Tromethamine 
Packaging
#Item CodePackage Description
1NDC:58232-0750-259 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34803/22/2012
Labeler - Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. (830803164)

Revised: 03/2012
 
Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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