SULFADERM- sulfur ointment 
Pharmadel LLC

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.

----------

Sulfaderm Acne Treatment Sulfur 10%

Drug Facts

Drug Facts

Active ingredient & Purpose

Active ingredient

Purpose
Sulfur 10% ........................Acne treatment

Uses

For the treatment of acne. Clears up acne:

  • blemishes
  • pimples
  • blackheads
  • whiteheads

Warnings

For external use only. Avoid contact with the eyes.

Do not use on

  • broken skin
  • large areas of the skin

When using this product

  • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • apply only to areas with acne

If pregnant or breast feeding,

ask a health professional before use

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • cleanse the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Other information

  • store between (59-86°F) 15-30°C
  • don’t use if clear seal over cap is broken, torn, or missing

Inactive ingredients

cetyostearyl alcohol, glycerin, glyceryl monostearate, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, polyethylene

glycol, sorbitan monooleate, water

Distributed by:

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

Principal Display Panel

PDP Sulfur

SULFADERM 
sulfur ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-379
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-379-0257 g in 1 JAR; Type 0: Not a Combination Product06/10/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00606/10/2023
Labeler - Pharmadel LLC (030129680)

Revised: 6/2023
Document Id: fdcaaa56-a27e-5bd9-e053-6294a90a1160
Set id: fdcaaa56-a27d-5bd9-e053-6294a90a1160
Version: 1
Effective Time: 20230610
 
Pharmadel LLC