SPL v4
SPL
SPL Set ID b79d3096-c609-e710-e053-2995a90a8da2
Route
TOPICAL
Published
Effective Date 2021-02-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (1 g) Zinc Cation (0.1 g)
Inactive Ingredients
Decyl Oleate Trolamine Edetate Disodium Water Propylparaben Methylparaben Propylene Glycol Mineral Oil Sodium Cetostearyl Sulfate Cetostearyl Alcohol Stearic Acid .alpha.-tocopherol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-01
Description

Diphenhydramine hydrochloride 1% Zinc Acetate 0.1%

Purpose

Topical analgesic skin protectant

Medication Information

Purpose

Topical analgesic

skin protectant

Description

Diphenhydramine hydrochloride 1% Zinc Acetate 0.1%

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 50565-1

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

Section 51945-4

Itch stopping cream

Section 60561-8

protect from excessive heat (40°C/104°F)

Warnings

For external use only

Questions

drspharmacyusa.com

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 Ingredients

Diphenhydramine hydrochloride 1%

Zinc Acetate 0.1%

Inactive Ingredients

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, mineral oil, propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E

Ask A Doctor Before Use
  • on chicken pox
  • on measles
When Using This Product

When using this product avoid contact with eyes

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

Structured Label Content

Uses (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 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Itch stopping cream

Section 60561-8 (60561-8)

protect from excessive heat (40°C/104°F)

Purpose

Topical analgesic

skin protectant

Warnings (warnings)

For external use only

Questions

drspharmacyusa.com

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 Ingredients

Diphenhydramine hydrochloride 1%

Zinc Acetate 0.1%

Inactive Ingredients

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, mineral oil, propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E

Ask A Doctor Before Use (Ask a doctor before use)
  • on chicken pox
  • on measles
When Using This Product (When using this product)

When using this product avoid contact with eyes

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:19.182516 · Updated: 2026-03-14T23:06:57.309434