Benadryl ®

Benadryl ®
SPL v10
SPL
SPL Set ID a1c1b878-d58f-41ff-b7a8-477f28c52667
Route
TOPICAL
Published
Effective Date 2024-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (20 mg) Zinc Cation (1 mg)
Inactive Ingredients
Cetyl Alcohol Diazolidinyl Urea Methylparaben Propylene Glycol Propylparaben Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-11-01

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 50566-9

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
Section 50567-7

When using this product avoid contact with eyes

Section 50569-3

Ask a doctor before use

  • on chicken pox
  • on measles
Section 50570-1

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Section 55105-1
Active ingredients Purpose
Diphenhydramine hydrochloride 2% Topical analgesic
Zinc acetate 0.1% Skin protectant
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
Other Information
  • protect from excessive heat (40˚C/104˚F)
Inactive Ingredients

cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, purified water

Questions Or Comments?

ca ll 1-877-717-2824 tol l-free or 215-273-8755 (co llect) www.benadryl.com

Principal Display Panel 28.3 G Tube Carton

Benadryl® ®

THE HISTAMINE

BLOCKER TM

Relief from most outdoor itches

EXTRA STRENGTH

For Ages 2+

ITCH STOPPING

CREAM

Diphenhydramine HCl 2%

/ Topical Analgesic

Zinc acetate 0.1% / Skin

Protectant

Insect Bites

Poison Ivy,

Oak, Sumac

Mosquito

Bites

Sunburn

Minor Cuts

& Scrapes

NET WT.1 OZ (28.3g)


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 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this product avoid contact with eyes

Section 50569-3 (50569-3)

Ask a doctor before use

  • on chicken pox
  • on measles
Section 50570-1 (50570-1)

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Section 55105-1 (55105-1)
Active ingredients Purpose
Diphenhydramine hydrochloride 2% Topical analgesic
Zinc acetate 0.1% Skin protectant
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
Other Information (Other information)
  • protect from excessive heat (40˚C/104˚F)
Inactive Ingredients (Inactive ingredients)

cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, purified water

Questions Or Comments? (Questions or comments?)

ca ll 1-877-717-2824 tol l-free or 215-273-8755 (co llect) www.benadryl.com

Principal Display Panel 28.3 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28.3 g Tube Carton)

Benadryl® ®

THE HISTAMINE

BLOCKER TM

Relief from most outdoor itches

EXTRA STRENGTH

For Ages 2+

ITCH STOPPING

CREAM

Diphenhydramine HCl 2%

/ Topical Analgesic

Zinc acetate 0.1% / Skin

Protectant

Insect Bites

Poison Ivy,

Oak, Sumac

Mosquito

Bites

Sunburn

Minor Cuts

& Scrapes

NET WT.1 OZ (28.3g)


Advanced Ingredient Data


Raw Label Data

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