Active Ingredient
Zinc Oxide 20%
Zinc Oxide 20%
FDA Label NDC 70512-103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sola Pharmaceuticals for the product Zinc Oxide 20% (NDC 70512-103). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin protectant
Uses
Skin Protectant
- Helps treat and prevent diaper rash
- Dries the ozzing and weeping of poison: •Ivy •Oak •Sumac
Warnings
For external use only
When using this product
- avoid contact with eyes
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
Stop use and ask a doctor if
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help
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
Package Label.Principal Display Panel
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
* Please review the disclaimer below.
