Extra Strength BENADRYL ITCH STOPPING GEL

Drug Labeling and Warnings

Drug Details [pdf]

BENADRYL EXTRA STRENGTH ITCH STOPPING- diphenhydramine hydrochloride gel 
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 GEL

Drug Facts

Active ingredient

Diphenhydramine HCl 2%

Purpose

Topical analgesic

Use

  • temporarily relieves pain and itching associated with:
    • insect bites
    • minor burns
    • sunburn
    • minor cuts
    • scrapes
    • minor skin irritations
    • rashes due to 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
  • 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

  • store at Room Temperature

Inactive ingredients

SD alcohol 38-B, camphor, citric acid, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Questions?

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

Dist: J&J Consumer Products Co. Div. of
J&J Consumer Companies Inc. Skillman, NJ 08558 USA

PRINCIPAL DISPLAY PANEL - 103 mL Tube Label

NEW LOOK and SIZE
SAME FORMULA!

EXTRA STRENGTH

Benadryl®

ITCH STOPPING
GEL
Diphenhydramine
Hydrochloride

FOR SKIN USE ONLY

Cooling relief for
Most outdoor itches

Insect
Bites

Poison Ivy,
Oak, Sumac

Mosquito
Bites

Sunburn

Minor Cuts
& Scrapes

3.5 FL OZ (103 mL)

PRINCIPAL DISPLAY PANEL - 103 mL Tube Label
BENADRYL EXTRA STRENGTH ITCH STOPPING 
diphenhydramine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58232-0744
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
Glycerin (UNII: PDC6A3C0OX)  
Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Propylparaben (UNII: Z8IX2SC1OH)  
Water (UNII: 059QF0KO0R)  
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58232-0744-3103 mL in 1 TUBE; Type 0: Not a Combination Product02/13/201309/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34802/13/201309/01/2019
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 9/2016