FDA Label for Benadryl Extra Strength Itch Stopping

View Indications, Usage & Precautions

Benadryl Extra Strength Itch Stopping Product Label

The following document was submitted to the FDA by the labeler of this product Kenvue Brands Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.

Skillman, NJ 08558


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

Otc - When Using



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

Otc - Keep Out Of Reach Of Children



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)


Principal Display Panel - 103 Ml Tube Label



EXTRA STRENGTH

Benadryl ®

ITCH STOPPING
GEL
Diphenhydramine
Hydrochloride
Topical Analgesic

FOR SKIN USE ONLY

Cooling relief for
most outdoor itches

Insect
Bites
Poison Ivy,
Oak, Sumac
Mosquito
Bites
SunburnMinor Cuts
& Scrapes

3.5 FL OZ (103 mL)


* Please review the disclaimer below.