Benadryl ®

Benadryl ®
SPL v9
SPL
SPL Set ID 66a2fd60-1757-45cc-a195-ecb9241dca2a
Route
TOPICAL
Published
Effective Date 2025-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (20 mg)
Inactive Ingredients
Alcohol Camphor (synthetic) Citric Acid Monohydrate Diazolidinyl Urea Glycerin Hypromellose, Unspecified Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-10-01

Description

Drug Facts

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Drug Facts

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
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

Warnings

For external use only.

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
Do Not Use
  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Active Ingredient

Diphenhydramine HCl 2%

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 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
  • symptoms persist for more than 7 days or clear up and occur again within a few days
Principal Display Panel 103 Ml Tube Label

Benadryl®

®

Cooling relief for

most outdoor itches

EXTRA STRENGTH

For Skin Use Only

ITCH STOPPING

GEL

Diphenhydramine HCl 2% /

Topical Analgesic

Insect



Bites
Poison Ivy,



Oak, Sumac
Mosquito



Bites
Sunburn Minor Cuts



& Scrapes

3.5 FL OZ (103 mL)


Structured Label Content

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
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

Purpose

Topical Analgesic

Warnings

For external use only.

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
Do Not Use (Do not use)
  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Active Ingredient (Active ingredient)

Diphenhydramine HCl 2%

Other Information (Other information)

Store at Room Temperature

Inactive Ingredients (Inactive ingredients)

SD alcohol 38-B, camphor, citric acid, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

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
  • symptoms persist for more than 7 days or clear up and occur again within a few days
Principal Display Panel 103 Ml Tube Label (PRINCIPAL DISPLAY PANEL - 103 mL Tube Label)

Benadryl®

®

Cooling relief for

most outdoor itches

EXTRA STRENGTH

For Skin Use Only

ITCH STOPPING

GEL

Diphenhydramine HCl 2% /

Topical Analgesic

Insect



Bites
Poison Ivy,



Oak, Sumac
Mosquito



Bites
Sunburn Minor Cuts



& Scrapes

3.5 FL OZ (103 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)