Active Ingredients
Pyrithione Zinc, 0.1%
Sulfur 8 Oil Moisturizer Anti-dandruff Lotion
FDA Label NDC 12022-019
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by J. Strickland & Co. for the product Sulfur 8 Oil Moisturizer Anti-dandruff (NDC 12022-019). 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 ingredients, purpose, use:, warnings:, when using this product, stop use and consult a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antidandruff
Use:
Controls scalp itching and flaking due to dandruff
Warnings:
For external use only
When Using This Product
- do not get into eyes. If contact occurs, rinse eyes thoroughly with water.
Stop Use And Consult A Doctor If
- condition worsens or does not improve after regular use
Keep Out Of Reach Of Children
If swallowed, get medical help or call a poison control center at once.
Directions
- Spray to apply to the affected area 1-4 times daily, or as directed by a doctor.
Inactive Ingredients
Water, Glycerin, PEG-12 Dimethicone, Propylene Glycol, Sodium Hydroxide, Hydrolyzed Collagen, Disodium EDTA, Diazolidinyl Urea, Fragrance, Methylparaben, Propylparaben.
Package Labeling
12022-019-00 (12022 019 00)
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