SPL v1
SPL
SPL Set ID 34a66224-ef3c-e36e-e063-6394a90ac99d
Route
TOPICAL
Published
Effective Date 2025-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (0.1 g) Diphenhydramine (2 g)
Inactive Ingredients
Polyethylene Glycol 1000 Diazolidinyl Urea Methylparaben Propylene Glycol Cetyl Alcohol Stearyl Alcohol Water Propylparaben

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

Diphenhydramine hydrochloride 2% Zinc acetate 0.1%


Medication Information

Warnings and Precautions

For external use only

Description

Diphenhydramine hydrochloride 2% Zinc acetate 0.1%

Uses

temporarily relieves pain and itching due to:

  • insect bites
  • minor burns
  • sunburns
  • minor skin irritations
  • minor cuts
  • scrapes
  • rashes due to poison ivy, poison oak and poison sumac
  • dries the oozing and weeping of poison:
    • Ivy
    • oak
    • sumac
Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

ceytl alcohol

diazolindinyl urea

methlparaben

polyethylene glycol

monostearate 1000

propylene glycol

propylparaben

purified water

stearyl alcohol

Section 51945-4

Section 53413-1

www.mygnp.com

Section 55105-1

Diphenhydramine hydrochloride...............Topical anagesic

Zinc acetate..............................................Skin protectant

Section 60561-8

Store at 20C to 25C (68F to 77F)

Directions

do not use more often then directed

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask doctor

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Ask Doctor Section

conditions worsen

symptoms last more than 7 days or clear up and occur again within a few days

Do Not Use Section

on chicken pox, poison ivy, sunburn, large areas of the body, broken, blistered, or oozing skin, more often than directed, or with any other product containing diphenhydramine, even one taken by mouth


Structured Label Content

Uses

temporarily relieves pain and itching due to:

  • insect bites
  • minor burns
  • sunburns
  • minor skin irritations
  • minor cuts
  • scrapes
  • rashes due to poison ivy, poison oak and poison sumac
  • dries the oozing and weeping of poison:
    • Ivy
    • oak
    • sumac
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

ceytl alcohol

diazolindinyl urea

methlparaben

polyethylene glycol

monostearate 1000

propylene glycol

propylparaben

purified water

stearyl alcohol

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

www.mygnp.com

Section 55105-1 (55105-1)

Diphenhydramine hydrochloride...............Topical anagesic

Zinc acetate..............................................Skin protectant

Section 60561-8 (60561-8)

Store at 20C to 25C (68F to 77F)

Directions

do not use more often then directed

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask doctor

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Ask Doctor Section

conditions worsen

symptoms last more than 7 days or clear up and occur again within a few days

Do Not Use Section (Do not use section)

on chicken pox, poison ivy, sunburn, large areas of the body, broken, blistered, or oozing skin, more often than directed, or with any other product containing diphenhydramine, even one taken by mouth


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)