Zinc Oxide Cream

Zinc Oxide Cream
SPL v1
SPL
SPL Set ID 70f85a4a-d4d6-4863-bdb3-2ef8d85986e7
Route
TOPICAL
Published
Effective Date 2022-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (22 g)
Inactive Ingredients
Aloe Vera Leaf Caprylyl Glycol Polyoxyl 20 Cetostearyl Ether Cetyl Alcohol Chlorphenesin Glycerin Mineral Oil Phenoxyethanol Water Stearyl Alcohol .alpha.-tocopherol Acetate White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-05-01
Description

Zinc Oxide 22%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide 22%

Uses

• helps treat and prevent diaper rash

• protects chafed skin due to diaper rash and helps protect skin from wetness.

Section 42229-5

Manufactured for 

Emerging Pharmaceuticals

New Jersey, USA

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.
Package Label

NDC 70050-100-04 NET WT: 4 oz (113 grams)

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, caprylyl glycol, ceteareth- 20, cetyl alcohol, chlorphenesin, glycerine, mineral oil, phenoxyethanol, purified water, stearyl alcohol, tocopheryl acetate (vitamin E), 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

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)

Manufactured for 

Emerging Pharmaceuticals

New Jersey, USA

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.
Package Label

NDC 70050-100-04 NET WT: 4 oz (113 grams)

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, caprylyl glycol, ceteareth- 20, cetyl alcohol, chlorphenesin, glycerine, mineral oil, phenoxyethanol, purified water, stearyl alcohol, tocopheryl acetate (vitamin E), 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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:12.340720 · Updated: 2026-03-14T23:00:34.965652