111medco 6% Sulfur Skin Cleansing Bar

111medco 6% Sulfur Skin Cleansing Bar
SPL v5
SPL
SPL Set ID 7a2d647f-f10f-4637-b28b-319fed93677b
Route
TOPICAL
Published
Effective Date 2023-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (60 mg)
Inactive Ingredients
Sodium Palmate Sodium Cocoate Sodium Palm Kernelate Water Glycerin Tangerine Sodium Chloride Tetrasodium Glutamate Diacetate Rosemary

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-06

Description

Sulfur 6%

Purpose

Acne


Medication Information

Purpose

Acne

Description

Sulfur 6%

Uses
  • Cleansing soap for the management of acne.
Warnings

For external use only

Directions
  • Apply liberally over wet skin with a clean wash cloth or body puff, concentrating on problem areas, avoiding contact with eye
  • Rinse thoroughly and pat dry with a clean towel
  • Because bothersome dryness of the skin may occur, start with one use daily, then gradually increase to two or three times daily if needed
  • If bothersome drying or peeling occurs, reduce use to once a day or every other day
Active Ingredient

Sulfur 6%

Package Labeling:

Inactive Ingredients

Sodium palmate, sodium cocoate*, sodium palm kernelate*, agua, glycerin, tangerine extract, sodium chloride, tetrasodium glutamate diacetate, rosemary leaf extract. (*may contain this ingredient)

When Using This Product

Skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a healthcare provider.

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • Cleansing soap for the management of acne.
Purpose

Acne

Warnings

For external use only

Directions
  • Apply liberally over wet skin with a clean wash cloth or body puff, concentrating on problem areas, avoiding contact with eye
  • Rinse thoroughly and pat dry with a clean towel
  • Because bothersome dryness of the skin may occur, start with one use daily, then gradually increase to two or three times daily if needed
  • If bothersome drying or peeling occurs, reduce use to once a day or every other day
Active Ingredient (Active ingredient)

Sulfur 6%

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Sodium palmate, sodium cocoate*, sodium palm kernelate*, agua, glycerin, tangerine extract, sodium chloride, tetrasodium glutamate diacetate, rosemary leaf extract. (*may contain this ingredient)

When Using This Product (When using this product)

Skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a healthcare provider.

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

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


Advanced Ingredient Data


Raw Label Data

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