Zinc Oxide

Zinc Oxide
SPL v9
SPL
SPL Set ID 7e045b3a-f33b-4faa-ab9b-2baec6ff7924
Route
TOPICAL
Published
Effective Date 2023-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (22 g)
Inactive Ingredients
Cetyl Alcohol Mineral Oil Aloe Vera Leaf Glycerin Water Stearyl Alcohol .alpha.-tocopherol Acetate Petrolatum Glyceryl Stearate Se Isopropyl Palmitate Peg-100 Monostearate Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-29

Description

Drug Facts

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Drug Facts

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect skin from wetness.
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 do not get into eyes

Warnings

For external use only

Directions
  • change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Questions?

Call 1-844-221-7294.

Active Ingredient

Zinc Oxide 22%

Other Information
  • store at 20-30°C (68-86 °F)
Inactive Ingredients

aloe barbadensis leaf juice, cetyl alcohol, glycerin, glyceryl stearate SE, isopropyl palmitate, mineral oil, PEG-100 stearate, phenoxyethanol, purified water, tocopheryl acetate (vitamin E), stearyl alcohol, white petrolatum

Stop Use and Ask A Doctor If
  • conditions worsen
  • symptoms last more than 7 days or clear up and occur again within a few days
Principal Display Panel 113 Gram Tube Label

Soothing Aloe &

Vitamin E

NDC 69367-188-04

Zinc Oxide 22%

Daily Moisturizing

Diaper Rash Cream

Premium Skin Protectant

  • Helps Heal, Soothe & Prevent Diaper Rash
  • Protects Chafed Skin
  • Gentle on Sensitive Skin

NET WT: 4 oz (113 grams)

Westminster

Pharmaceuticals


Structured Label Content

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect skin from wetness.
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 do not get into eyes

Purpose

Skin Protectant

Warnings

For external use only

Directions
  • change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Questions?

Call 1-844-221-7294.

Active Ingredient (Active ingredient)

Zinc Oxide 22%

Other Information (Other information)
  • store at 20-30°C (68-86 °F)
Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, cetyl alcohol, glycerin, glyceryl stearate SE, isopropyl palmitate, mineral oil, PEG-100 stearate, phenoxyethanol, purified water, tocopheryl acetate (vitamin E), stearyl alcohol, white petrolatum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • conditions worsen
  • symptoms last more than 7 days or clear up and occur again within a few days
Principal Display Panel 113 Gram Tube Label (PRINCIPAL DISPLAY PANEL - 113 gram Tube Label)

Soothing Aloe &

Vitamin E

NDC 69367-188-04

Zinc Oxide 22%

Daily Moisturizing

Diaper Rash Cream

Premium Skin Protectant

  • Helps Heal, Soothe & Prevent Diaper Rash
  • Protects Chafed Skin
  • Gentle on Sensitive Skin

NET WT: 4 oz (113 grams)

Westminster

Pharmaceuticals


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)