Benadryl ®

Benadryl ®
SPL v8
SPL
SPL Set ID 309d9be0-e367-429a-a1fa-ab7855477c8a
Route
TOPICAL
Published
Effective Date 2025-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (1 mg) Diphenhydramine (20 mg)
Inactive Ingredients
Alcohol Water Povidone, Unspecified Glycerin Tromethamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-06-01

Description

Drug Facts


Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product avoid contact with eyes

Section 55105-1
Active ingredient Purpose
Diphenhydramine HCl 2% Topical analgesic
Zinc acetate 0.1% Skin protectant
Warnings

For external use only.

Flammable. Keep away from fire or flame.

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
Do Not Use
  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Other Information
  • store at 20° to 25° C (68° to 77° F)
Inactive Ingredients

alcohol, glycerin, PVP, purified water, tromethamine

Questions Or Comments?

call 1-877-717-2824 (toll-free) or 215-273-8755 (collect) www.benadryl.com

Ask A Doctor Before Use
  • on chicken pox
  • on measles
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
Principal Display Panel 14 Ml Applicator Carton

Benadryl ® ®

Apply directly

to insect bites

EXTRA STRENGTH

For Ages 2+

ITCH

RELIEF

STICK

Diphenhydramine HCL 2% /

Topical Analgesic

Zinc acetate 0.1% /

Skin Protectant

Starts working

on contact

Relieves itch

and pain

Insect Mosquito

Bites Bites

0.47 FL OZ (14mL)


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes

Section 55105-1 (55105-1)
Active ingredient Purpose
Diphenhydramine HCl 2% Topical analgesic
Zinc acetate 0.1% Skin protectant
Warnings

For external use only.

Flammable. Keep away from fire or flame.

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
Do Not Use (Do not use)
  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Other Information (Other information)
  • store at 20° to 25° C (68° to 77° F)
Inactive Ingredients (Inactive ingredients)

alcohol, glycerin, PVP, purified water, tromethamine

Questions Or Comments? (Questions or comments?)

call 1-877-717-2824 (toll-free) or 215-273-8755 (collect) www.benadryl.com

Ask A Doctor Before Use (Ask a doctor before use)
  • on chicken pox
  • on measles
Stop Use and Ask A Doctor If (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
Principal Display Panel 14 Ml Applicator Carton (PRINCIPAL DISPLAY PANEL - 14 mL Applicator Carton)

Benadryl ® ®

Apply directly

to insect bites

EXTRA STRENGTH

For Ages 2+

ITCH

RELIEF

STICK

Diphenhydramine HCL 2% /

Topical Analgesic

Zinc acetate 0.1% /

Skin Protectant

Starts working

on contact

Relieves itch

and pain

Insect Mosquito

Bites Bites

0.47 FL OZ (14mL)


Advanced Ingredient Data


Raw Label Data

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