Benadryl ®

Benadryl ®
SPL v7
SPL
SPL Set ID 920c50cb-9bdd-4a36-bb3d-c2559db73327
Route
TOPICAL
Published
Effective Date 2024-11-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (10 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 2020-01-31

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 ingredients Purpose
Diphenhydramine hydrochloride 1% 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
Do Not Use
  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Questions?

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

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

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 28.3 G Tube Carton

Benadryl ® ®

THE HISTAMINE BLOCKER TM

Relief from most outdoor itches

ORIGINAL STRENGTH

For Ages 2+

ITCH STOPPING

CREAM

Diphenhydramine HCl 1%/

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 50567-7 (50567-7)

When using this product avoid contact with eyes

Section 55105-1 (55105-1)
Active ingredients Purpose
Diphenhydramine hydrochloride 1% 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
Do Not Use (Do not use)
  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Questions?

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

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

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 28.3 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28.3 g Tube Carton)

Benadryl ® ®

THE HISTAMINE BLOCKER TM

Relief from most outdoor itches

ORIGINAL STRENGTH

For Ages 2+

ITCH STOPPING

CREAM

Diphenhydramine HCl 1%/

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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