SULFADERM- sulfur ointment

Sulfaderm by

Drug Labeling and Warnings

Sulfaderm by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SULFADERM 
sulfur ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-379
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-379-02	57 g in 1 JAR; Type 0: Not a Combination Product	06/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	06/10/2023

Labeler - Pharmadel LLC (030129680)