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)

BENADRYL EXTRA STRENGTH ITCH STOPPING 
diphenhydramine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58232-0744
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58232-0744-3	103 mL in 1 TUBE; Type 0: Not a Combination Product	02/13/2013	09/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	02/13/2013	09/01/2019

Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 9/2016

Document Id: df142e2a-a383-455b-9051-788b7fc6971d

Set id: f230079e-41f3-40f2-93f0-4052e5d84095

Version: 3

Effective Time: 20160906