CHILDRENS BENADRYL ITCH COOLING- camphor (synthetic) 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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Children's Benadryl Itch Cooling Gel

Drug Facts

Active ingredient

Camphor 0.45%

Purpose

External analgesic

Use

temporarily relieves pain and itching associated with:

  • minor burns
  • sunburn
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations
  • rashes due to poison ivy, poison oak, and poison sumac

Warnings

For external use only.

Flammable: Keep away from fire or flame

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

  • 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 20° to 25° C (68° to 77° F)

Inactive ingredients

carbomer, EDTA, SD alcohol 40-B, trolamine, water

Questions?

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

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

Children's
Benadryl®
Camphor External Analgesic

ITCH COOLING GEL

Cooling, soothing
relief for most
outdoor itches

Stops the urge to scratch

For kids 2+

Insect Bites                                FOR SKIN
Poison Ivy, Oak, Sumac            USE ONLY
Mosquito Bites
Sunburn
Minor Cuts & Scrapes

Does Not Contain Diphenhydramine

NET WT 3 OZ (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Label
CHILDRENS BENADRYL ITCH COOLING 
camphor (synthetic) gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-0751
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Edetic Acid (UNII: 9G34HU7RV0)  
Trolamine (UNII: 9O3K93S3TK)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58232-0751-385 g in 1 TUBE; Type 0: Not a Combination Product04/27/201210/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34804/27/201210/01/2018
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 10/2016
Document Id: cbccd266-b375-472e-8ce8-07c4c21799ce
Set id: aa54029b-1604-4b34-8ce7-a8b5f0305567
Version: 3
Effective Time: 20161020
 
Johnson & Johnson Consumer Inc.