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Sulfur 8 Oil Moisturizer Anti-Dandruff

Dosage form: lotion
Ingredients: PYRITHIONE ZINC 1mg in 1mL
Labeler: J. Strickland & Co.
NDC Code: 12022-019

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Sulfur 8 Oil Moisturizer Anti-Dandruff Lotion

Active Ingredients

Pyrithione Zinc, 0.1%

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

SULFUR 8 OIL MOISTURIZER ANTI-DANDRUFF 
pyrithione zinc lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12022-019
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
MINERAL OIL 
ALOE VERA LEAF 
ISOPROPYL MYRISTATE 
STEARYL ALCOHOL 
POLYOXYL 20 CETOSTEARYL ETHER 
JOJOBA OIL 
PROPYLENE GLYCOL 
.ALPHA.-TOCOPHEROL ACETATE 
METHYLPARABEN 
PROPYLPARABEN 
DIAZOLIDINYL UREA 
SODIUM LAURYL SULFATE 
PANTHENOL 
Packaging
#Item CodePackage Description
1NDC:12022-019-00237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/07/2005
Labeler - J. Strickland & Co. (007023112)
Registrant - J. Strickland & Co. (007023112)
Establishment
NameAddressID/FEIOperations
J. Strickland & Co.007023112manufacture(12022-019), pack(12022-019), label(12022-019)

Revised: 01/2018
 
J. Strickland & Co.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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