SPL v3
SPL
SPL Set ID 4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1
Route
TOPICAL
Published
Effective Date 2024-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (200 mg)
Inactive Ingredients
Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-29

Description

Active Ingredient Zinc oxide 20%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Active Ingredient Zinc oxide 20%

Uses
  • helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Section 50566-9

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days to clear up and occur again within a few days
Section 50567-7

When using this product, avoid contact with the eyes

Warnings

For external use only

Directions
  • apply liberally as often as necessary

For Diaper Rash

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

For Poison Ivy, poison oak and poison sumac;

  • cleanse the affect area and pat dry 
  • apply ointment liberally, as often as necessary, using a cotton ball, sterile swab or gauze
  • wash hands after use.
Drug Facts

Active Ingredient

Zinc oxide 20%

Inactive Ingredients

mineral oil, petrolatum

Questions Or Comments?

Call 1-800-222-1087

Store at room temperature 20 - 25°C (68° - 77°F).

Principal Display Panel – Jar Label

Leader®       NDC 70000-0334-1

Zinc Oxide

Ointment USP•

Multi Purpose Skin Protectant 

provides soothing relief from poison ivy,

oak and sumac

Treats and prevents diaper rash

Net Wt 1 lb (454 g)


Structured Label Content

Uses
  • helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.
  • dries the oozing and weeping of poison ivy, poison oak and 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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days to clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product, avoid contact with the eyes

Purpose

Skin Protectant

Warnings

For external use only

Directions
  • apply liberally as often as necessary

For Diaper Rash

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

For Poison Ivy, poison oak and poison sumac;

  • cleanse the affect area and pat dry 
  • apply ointment liberally, as often as necessary, using a cotton ball, sterile swab or gauze
  • wash hands after use.
Drug Facts

Active Ingredient

Zinc oxide 20%

Inactive Ingredients (Inactive ingredients)

mineral oil, petrolatum

Questions Or Comments? (Questions or comments?)

Call 1-800-222-1087

Store at room temperature 20 - 25°C (68° - 77°F).

Principal Display Panel – Jar Label

Leader®       NDC 70000-0334-1

Zinc Oxide

Ointment USP•

Multi Purpose Skin Protectant 

provides soothing relief from poison ivy,

oak and sumac

Treats and prevents diaper rash

Net Wt 1 lb (454 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)