zinc oxide 20% ointment

zinc oxide 20% ointment
SPL v3
SPL
SPL Set ID c091d3ed-f317-9193-e053-2a95a90a4917
Route
topical
Published
Effective Date 2021-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (200 mg)
Inactive Ingredients
ceteth-20 petrolatum cetostearyl alcohol mineral oil

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2021-04-22

Purpose

Skin protectant

Description

Zinc Oxide 20%


Medication Information

Warnings

For external use only

When using this product

  • avoid contact with 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
Uses

Skin Protectant

  • Helps treat and prevent diaper rash
  • Dries the ozzing and weeping of poison: •Ivy •Oak •Sumac
Purpose

Skin protectant

Directions
  • For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply paste liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
  • For poison ivy, oak, and sumac: Apply as needed
Other Information
  • Store at room temperature
  • Avoid excessive heat and humidity
Inactive Ingredients

Cetomacrogol 1000, Cetostearyl alcohol, Mineral oil, Petrolatum

Description

Zinc Oxide 20%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help

Section 51945-4

Questions of comments? Call 1-866-747-7365

Manufactured for : SOLA Pharmaceuticals



Baton Rouge, LA 70810



Store at room temperature. Avoid excessive heat and humidity.

Zinc Oxide 20% Ointment



NDC 70512-103-30



Qty: 28.4g

Active Ingredient

Zinc Oxide 20%


Structured Label Content

Warnings

For external use only

When using this product

  • avoid contact with 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
Uses

Skin Protectant

  • Helps treat and prevent diaper rash
  • Dries the ozzing and weeping of poison: •Ivy •Oak •Sumac
Purpose

Skin protectant

Directions
  • For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply paste liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
  • For poison ivy, oak, and sumac: Apply as needed
Other Information
  • Store at room temperature
  • Avoid excessive heat and humidity
Inactive Ingredients (Inactive ingredients)

Cetomacrogol 1000, Cetostearyl alcohol, Mineral oil, Petrolatum

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help

Section 51945-4 (51945-4)

Questions of comments? Call 1-866-747-7365

Manufactured for : SOLA Pharmaceuticals



Baton Rouge, LA 70810



Store at room temperature. Avoid excessive heat and humidity.

Zinc Oxide 20% Ointment



NDC 70512-103-30



Qty: 28.4g

Active Ingredient

Zinc Oxide 20%


Advanced Ingredient Data


Raw Label Data

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