Sulfaderm Acne Treatment (wp)(da)

Sulfaderm Acne Treatment (wp)(da)
SPL v3
SPL
SPL Set ID fdcaaa56-a27d-5bd9-e053-6294a90a1160
Route
TOPICAL
Published
Effective Date 2023-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (10 g)
Inactive Ingredients
Water Cetostearyl Alcohol Glyceryl Monostearate Methylparaben Mineral Oil Paraffin Petrolatum Polyethylene Glycol, Unspecified Propylparaben Sorbitan Monooleate Glycerin

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-06-10 Until 2026-04-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

For the treatment of acne. Clears up acne:

  • blemishes
  • pimples
  • blackheads
  • whiteheads
Section 55105-1

Active ingredient

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

Warnings

For external use only. Avoid contact with the eyes.

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
Drug Facts

Drug Facts

Do Not Use On
  • broken skin
  • large areas of the skin
Distributed By:

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

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

Principal Display Panel

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.


Structured Label Content

Uses

For the treatment of acne. Clears up acne:

  • blemishes
  • pimples
  • blackheads
  • whiteheads
Section 55105-1 (55105-1)

Active ingredient

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

Warnings

For external use only. Avoid contact with the eyes.

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
Drug Facts

Drug Facts

Do Not Use On (Do not use on)
  • broken skin
  • large areas of the skin
Distributed By: (Distributed by:)

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

Other Information (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 (Inactive ingredients)

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

glycol, sorbitan monooleate, water

Principal Display Panel

When Using This Product (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, (If pregnant or breast feeding,)

ask a health professional before use

Keep Out of the Reach of Children. (Keep out of the reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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