Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 2e4f1d9b-35ba-4f7e-8fa0-df1af9f61f95
Route
TOPICAL
Published
Effective Date 2013-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (1.8 g)
Inactive Ingredients
Aloe Vera Leaf Alpha-tocopherol Ceteth-10 Cetostearyl Alcohol Cetyl Acetate Cholecalciferol Glycerin Lanolin Lavender Oil Methylparaben Mineral Oil Paraffin Petrolatum Phenoxyethanol Polyethylene Glycol 6000 Polysorbate 60 Propylparaben Sodium Steareth-20 Trolamine Vitamin A Water Fd&c Yellow No. 5 D&c Red No. 21

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-05-27
Description

Zinc Oxide (1.8%w/w)

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide (1.8%w/w)

Uses

■ helps treat and prevent diaper rash ■ temporarily protects minor ■ cuts ■ scrapes ■ burns dries the oozing and weeping of: ■ Poison ivy ■ poison oak ■ poison sumac

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only

Directions

■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak and sumac ■ apply ointment liberally as needed

Package Label

Active Ingredient

Zinc Oxide (1.8%w/w)

Other Information

■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat

Inactive Ingredients

aloe vera leaf, alpha-tocopherol, aeteth-10, cetostearyl alcohol, cetyl alcohol, cholecalciferol, glycerin, lanolin, lavender

methylparaben, mineral oil, paraffin, petrolatum, phenoxyethanol, polyethylene glycol 6000, polysorbate 60, propylparaben sodium

steareth-20, trolamine, vitamin A, water, FDC Yellow No.5, DC Red No.21

When Using This Product

■ do not get into eyes

Stop Use and Ask A Doctor If

if conditions worsen symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

Structured Label Content

Uses

■ helps treat and prevent diaper rash ■ temporarily protects minor ■ cuts ■ scrapes ■ burns dries the oozing and weeping of: ■ Poison ivy ■ poison oak ■ 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.

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 with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak and sumac ■ apply ointment liberally as needed

Package Label

Active Ingredient

Zinc Oxide (1.8%w/w)

Other Information

■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat

Inactive Ingredients (Inactive ingredients)

aloe vera leaf, alpha-tocopherol, aeteth-10, cetostearyl alcohol, cetyl alcohol, cholecalciferol, glycerin, lanolin, lavender

methylparaben, mineral oil, paraffin, petrolatum, phenoxyethanol, polyethylene glycol 6000, polysorbate 60, propylparaben sodium

steareth-20, trolamine, vitamin A, water, FDC Yellow No.5, DC Red No.21

When Using This Product (When using this product)

■ do not get into eyes

Stop Use and Ask A Doctor If (Stop Use and ask a doctor if)

if conditions worsen symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:24.885951 · Updated: 2026-03-14T22:54:51.534540