Benadryl Extra Strength Itch Relief Solution
FDA Label NDC 69968-0459

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Benadryl Extra Strength Itch Relief (NDC 69968-0459). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, do not use, ask a doctor before use, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Other

Drug Facts

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

Otc - Purpose

Active ingredientPurpose
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
  • hold stick straight down over affected skin area
  • press tip of stick repeatedly on affected skin area until liquid flows, then dab sparingly
  • 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

alcohol, water, PVP, glycerin, tromethamine

Questions?

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

Principal Display Panel - 14 Ml Applicator Carton

EXTRA STRENGTH
Benadryl ®
Topical Analgesic/Skin Protectant

ITCH
RELIEF
STICK

Apply
directly
to insect
bites

Starts working
on contact

Relieves itch
and pain

For adults
and kids 2+

Insect
Bites

Mosquito
Bites

0.47 FL OZ (14 mL)

Principal Display Panel (14 mL Applicator Carton)

Principal Display Panel (14 mL Applicator Carton)

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