SULFUR- sulfur ointment
World Perfumes, Inc

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.

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Active Ingredient Purpose

Sulfur 10% ...................... ointment

Sulfur 10% ointment

Keep out of reach of children.

Sulfur 10% Ointment

cetyl/stearyl alcohol, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, polyethylenglycol, propylparaben, sorbitan oleate, water

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SULFUR
sulfur ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10095-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10095-007-01	57 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	05/05/2015

Labeler - World Perfumes, Inc (101312044)

Name	Address	ID/FEI	Business Operations
Establishment
World Perfumes, Inc		101312044	manufacture(10095-007)