Anti-itch Cream

Anti-itch Cream
SPL v4
SPL
SPL Set ID 79fd6b63-5fd4-4ab0-81df-e9d582984ace
Route
TOPICAL
Published
Effective Date 2015-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (0.02 g) Zinc Cation (0.001 g)
Inactive Ingredients
Aloe Vera Leaf .alpha.-tocopherol Water Cetyl Alcohol Diazolidinyl Urea Methylparaben Peg-20 Stearate Propylene Glycol Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-04-15
Description

Active Ingredients Diphenhydramine Hydrochloride  2% Zinc Acetate  0.1%

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

For the temporary relief of pain and itching associated with:

  • minor skin irritation
  • allergic itches
  • rashes
  • hives
  • minor burns
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
Dosage and Administration

Directions

  • For children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

  • For children under 2 years of age: consult a physician.

Description

Active Ingredients Diphenhydramine Hydrochloride  2% Zinc Acetate  0.1%

Section 42229-5

Other information

  • Store at 20ºC to 25ºC (68ºF to 77ºF).
Section 50565-1

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor

  • if condition worsens
  • symptoms persist for 7 days or clear up and occur again within a few days.
Section 50570-1

Do not use on children under 2 years of age.

For external use only

  • avoid contact with eyes
  • do not apply to open wound or damaged skin.
Section 51727-6

Inactive ingredients

Cetyl Alcohol, Diazolidinly urea, Methylparaben, Polyethylene Glycol Monostearate 1000, Propylene Gylcol, Propylparaben, Aloevera extract, Alpha-Tocopherol Acetate, Purified Water.

Section 51945-4

PRINCIPAL DISPLAY PANEL

Anti-Itch Cream

NET WT 1 OZ (28 g)

Section 55105-1

Purpose

Topical Analgesic

Skin Protectant

Section 55106-9

Active Ingredients

Diphenhydramine Hydrochloride  2%

Zinc Acetate  0.1%

Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of pain and itching associated with:

  • minor skin irritation
  • allergic itches
  • rashes
  • hives
  • minor burns
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
Dosage and Administration (34068-7)

Directions

  • For children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

  • For children under 2 years of age: consult a physician.

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Other information

  • Store at 20ºC to 25ºC (68ºF to 77ºF).
Section 50565-1 (50565-1)

Keep out of reach of children.

In case of accidental ingestion, 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
  • symptoms persist for 7 days or clear up and occur again within a few days.
Section 50570-1 (50570-1)

Do not use on children under 2 years of age.

For external use only

  • avoid contact with eyes
  • do not apply to open wound or damaged skin.
Section 51727-6 (51727-6)

Inactive ingredients

Cetyl Alcohol, Diazolidinly urea, Methylparaben, Polyethylene Glycol Monostearate 1000, Propylene Gylcol, Propylparaben, Aloevera extract, Alpha-Tocopherol Acetate, Purified Water.

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

Anti-Itch Cream

NET WT 1 OZ (28 g)

Section 55105-1 (55105-1)

Purpose

Topical Analgesic

Skin Protectant

Section 55106-9 (55106-9)

Active Ingredients

Diphenhydramine Hydrochloride  2%

Zinc Acetate  0.1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:44.422042 · Updated: 2026-03-14T23:05:38.431426