SPL v2
SPL
SPL Set ID 65d4acc8-6936-3fd3-e053-2991aa0ab3d3
Route
TOPICAL
Published
Effective Date 2018-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (10 mg) Zinc Cation (1 mg)
Inactive Ingredients
Water Propylparaben Methylparaben Decyl Oleate Sodium Cetostearyl Sulfate Trolamine Propylene Glycol Cetostearyl Alcohol Edetic Acid Stearic Acid .alpha.-tocopherol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-02-21
Description

Diphenhydramine hydrochloride 1% Zinc Acetate 0.1%

Medication Information

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 50567-7

When using this product avoid contact with eyes

Section 51945-4

Net weight 20 g

NDC#70648-133-01

Section 55105-1

Topical analgesic

skin protectant

Warnings

For external use only.

Questions

www.ohiolabpharma.us

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
Other Information

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

Active Ingredients

Diphenhydramine hydrochloride 1%

Zinc Acetate 0.1%

Inactive Ingredients

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

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

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 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 51945-4 (51945-4)

Net weight 20 g

NDC#70648-133-01

Section 55105-1 (55105-1)

Topical analgesic

skin protectant

Warnings (warnings)

For external use only.

Questions

www.ohiolabpharma.us

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
Other Information (Other information)

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

Active Ingredients (ACTIVE INGREDIENTS)

Diphenhydramine hydrochloride 1%

Zinc Acetate 0.1%

Inactive Ingredients (inactive ingredients)

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, decyl oleate, 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
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: 2026-02-15T11:56:41.021713 · Updated: 2026-03-14T22:55:19.604592