CHILDRENS BENADRYL ITCH COOLING (camphor- synthetic gel

Childrens Benadryl Itch Cooling by

Drug Labeling and Warnings

Childrens Benadryl Itch Cooling by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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)

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Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

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)

INGREDIENTS AND APPEARANCE

CHILDRENS BENADRYL ITCH COOLING 
camphor (synthetic) gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0241
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Carboxypolymethylene (UNII: 0A5MM307FC)
Edetic Acid (UNII: 9G34HU7RV0)
Trolamine (UNII: 9O3K93S3TK)
Water (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0241-3	85 g in 1 TUBE; Type 0: Not a Combination Product	11/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	11/01/2013

Labeler - Johnson & Johnson Consumer Inc. (002347102)