1195, 1196

1195, 1196
SPL v9
SPL
SPL Set ID 59fd865c-b81d-43ad-8fa0-c37ca0557769
Route
TOPICAL
Published
Effective Date 2018-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (1.8 g)
Inactive Ingredients
Vitamin A Acetate Fd&c Yellow No. 5 Lavender Oil Alpha-tocopherol Aloe Vera Leaf Trolamine Water Lanolin Ceteth-20 Mineral Oil Methylparaben Propylparaben Glycerin Cetyl Alcohol Cetostearyl Alcohol Cholecalciferol White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-01
Description

Zinc Oxide 1.8%

Purpose

​Skin Protectant

Medication Information

Purpose

​Skin Protectant

Description

Zinc Oxide 1.8%

Uses

  • Helps treat chafed skin associated with diaper rash
  • Temporarily protects minor • cuts • scrapes • burns
  • Dries the oozing and weeping of poison ivy, oak, sumac
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Warnings

For External Use Only

1195 Label

1196 Label

Directions
  • For diaper rash: 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.
  • For other uses: Apply as needed.
Active Ingredient

Zinc Oxide 1.8%

Other Information
  • Store at room temperature between 15º-30ºC (59°-86°F)
  • Avoid excessive heat
  • Tamper evident. Do not use if seal is damaged.
Inactive Ingredients

Glycerin, Cetostearyl Alcohol, Cetyl Alcohol, White Soft Paraffin, Mineral Oil, Lanolin, Cetomacrogol 1000, Aloe Vera Leaf, Methyl Paraben, Propyl Paraben, Perfume Lavander Oil, Alpha Tocopherol, Trolamine, Vitamin A Acetate, Cholecalciferol (Vitamin D3), FD&C Yellow No. 5 (Tartrazine), Water

When Using This Product
  • Do not get in eyes
Stop Use and Ask A Doctor If
  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days

Structured Label Content

Uses

  • Helps treat chafed skin associated with diaper rash
  • Temporarily protects minor • cuts • scrapes • burns
  • Dries the oozing and weeping of poison ivy, oak, sumac
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Purpose

​Skin Protectant

Warnings

For External Use Only

1195 Label

1196 Label

Directions
  • For diaper rash: 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.
  • For other uses: Apply as needed.
Active Ingredient

Zinc Oxide 1.8%

Other Information
  • Store at room temperature between 15º-30ºC (59°-86°F)
  • Avoid excessive heat
  • Tamper evident. Do not use if seal is damaged.
Inactive Ingredients

Glycerin, Cetostearyl Alcohol, Cetyl Alcohol, White Soft Paraffin, Mineral Oil, Lanolin, Cetomacrogol 1000, Aloe Vera Leaf, Methyl Paraben, Propyl Paraben, Perfume Lavander Oil, Alpha Tocopherol, Trolamine, Vitamin A Acetate, Cholecalciferol (Vitamin D3), FD&C Yellow No. 5 (Tartrazine), Water

When Using This Product (When using this product)
  • Do not get in eyes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Condition worsens
  • 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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:29.239405 · Updated: 2026-03-14T23:05:15.511736