Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 73e0606c-677c-46d0-9388-2f2f1ff0a39b
Route
TOPICAL
Published
Effective Date 2011-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.10 g)
Inactive Ingredients
Aloe Vera Leaf Butylated Hydroxytoluene Mineral Oil Methylparaben Talc Alpha-tocopherol Acetate Trolamine Lanolin Water Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-09-12
Description

Zinc Oxide 10%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide 10%

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect skin from wetness
  • helps prevent and temporarily protect chafed, chapped, cracked or windburned skin lips

Warnings

For external use only

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

Do Not Use

over deep or puncture wounds, infections or lacerations

Package Label

QC Diaper Rash Cream

Active Ingredient

Zinc Oxide 10%

Other Information
  • store at room temperature
  • Lot No and Exp Date: see box or see crimp of tube

Inactive Ingredients

aloe vera gel, butylated hydroxytoluene, liquid paraffin, methyl parahydroxybenzoate, talc, tocopherol acetate, triethanolamine, purified lanolin, purified water, white petrolatum

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor

if condition worsens or does not improve within 7 days.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect skin from wetness
  • helps prevent and temporarily protect chafed, chapped, cracked or windburned skin lips

Purpose

Skin Protectant

Warnings

For external use only

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

Do Not Use (Do not use)

over deep or puncture wounds, infections or lacerations

Package Label (Package label)

QC Diaper Rash Cream

Active Ingredient (Active ingredient)

Zinc Oxide 10%

Other Information (Other information)
  • store at room temperature
  • Lot No and Exp Date: see box or see crimp of tube

Inactive Ingredients (Inactive ingredients)

aloe vera gel, butylated hydroxytoluene, liquid paraffin, methyl parahydroxybenzoate, talc, tocopherol acetate, triethanolamine, purified lanolin, purified water, white petrolatum

When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if condition worsens or does not improve within 7 days.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:21.084535 · Updated: 2026-03-14T22:52:53.430326