Active Ingredient(S)
Zinc oxide 100%
Zinc Oxide Granule
FDA Label NDC 87879-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shaanxi Shuvita Biotech Co., Ltd for the product Zinc Oxide (NDC 87879-004). 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(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
API Raw Material for Pharmaceutical Formulation
Use
For industrial use: Pharmaceutical intermediate raw material for formulation compounding, lab research & pharmacy manufacturing.
Warnings
When handling this product
■ May cause skin & eye irritation; wear full PPE (gloves, goggles, respirator)
■ Avoid direct skin contact, inhalation of dust
■ Do not ingest; keep separate from food, drinks
■ Keep away from ignition sources, strong oxidizers
■ Restless/irritability may occur with improper exposure, especially for personnel without chemical handling training
If pregnant/breastfeeding, consult industrial hygiene specialist before handling.
Keep out of reach of children & untrained personnel. In case of accidental ingestion/skin absorption/eye contact, flush affected area with plenty of clean water and seek emergency medical help immediately.
Do Not Use
Do not ingest
Otc - When Using
Avoid direct skin contact, inhalation of dust
Otc - Stop Use
When using this product keep out of eyes, ears, and mouth.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Industrial Storage & Handling Directions:
- Warehouse bulk storage: Seal drums tightly, store at 20–25°C (68-77°F)
- Avoid direct sunlight, excessive moisture & extreme temperature fluctuation
- Handling: Transfer under low-dust ventilation hood only
Other Information
store at 20-25° C (68-77° F) ■ protect from excessive moisture
Shelf life: 24 months from production date when properly stored
Inactive Ingredients
None
Package Label - Principal Display Panel
label
Undefined (Label)
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