FDA Label for Benadryl Extra Strength Itch Cooling

View Indications, Usage & Precautions

Benadryl Extra Strength Itch Cooling Product Label

The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer Inc.. 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.

Other



Drug Facts

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


Otc - Purpose



Active ingredientsPurpose
Diphenhydramine HCl 2%Topical analgesic
Zinc acetate 0.1%Skin protectant

Uses



  • temporarily relieves pain and itching associated with:
    • insect bites
    • minor burns
    • sunburn
    • minor skin irritations
    • minor cuts
    • scrapes
    • rashes due to poison ivy, poison oak, and poison sumac
    • dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings



For external use only.

Flammable. Keep away from fire or flame.


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 or does not improve within 7 days
  • 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: spray on 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



alcohol, glycerin, PVP, purified water, tromethamine


Questions?



call 1-800-524-2624 (English/Spanish)


Principal Display Panel - 59 Ml Bottle Label



EXTRA STRENGTH
Benadryl®
Topical Analgesic/Skin Protectant
ITCH COOLING SPRAY
Relief for most
outdoor itches

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

2 FL OZ (59 mL)


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