SPL v5
SPL
SPL Set ID a45c4f71-223b-169a-e053-2995a90acc86
Route
TOPICAL
Published
Effective Date 2020-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (5 g)
Inactive Ingredients
Salicylic Acid Cetyl Alcohol Polyoxyl 20 Cetostearyl Ether Gardenia Jasminoides Whole Acacia Bentonite Cetostearyl Alcohol Cranberry Juice Sodium Pidolate Citric Acid Monohydrate Phenoxyethanol Peppermint Oil Azelaic Acid Maltodextrin Tartaric Acid Eucalyptus Oil Glutathione Niacinamide Mentha Piperita Salix Nigra Bark Shea Butter Tocopherol Glycerin Tansy Oil Ethylhexylglycerin Kaolin Aloe Vera Leaf Alpha-tocopherol Acetate Alpha-arbutin Vitamin A Palmitate Xanthan Gum Green Tea Leaf Sodium Pyrrolidone Carboxylate Water Medium-chain Triglycerides Kojic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-28

Description

Sulfur 5%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Sulfur 5%

Uses:

For the treatment of acne

Section 51945-4

Warnings:

For external use only

Directions:

Clean the skin thoroguhly before applying this product. Cover the entire affected area with a thin layer. Leave on for 10-15 minutes. Rinse skin with warm water. Use 1-2 times a week. Can be applied on pimple as a spot treatment.

Active Ingredient

Sulfur 5%

Inactive Ingredients:

WATER, KAOLIN, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, NIACINAMIDE, GUM ARABIC, CETYL ALCOHOL, BENTONITE, CETEARYL ALCOHOL, CETEARETH-20, BUTYROSPERMUM PARKII (SHEA) BUTTER, SALICYCLIC ACID, HYDROLYZED ARDENIA FLORIDA EXTRACT, MENTHA PIPERITA (PEPPERMINT) OIL, EUCALYPTUS GLOBULUS LEAF OIL, SALIX NIGRA (WILLOW) BARK EXTRACT, TANACETUM ANNUUM, TOCOPHERYL ACETATE, ALOE BARBADENSIS LEAF JUICE, ALPHA-ARBUTIN, KOJIC ACID, AZELAIC ACID, RETINYL PALMITATE, TOCOPHEROL OIL, VACCINIUM MACOCARPON (CRANBERRY) FRUIT EXTRACT, XANTHAN GUM, MALTODEXTRIN, SODIUM PCA, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, GLUTATHIONE, TARTARIC ACID, CITRIC ACID, PHENOXYETHANOL, ETHYLHEXAYLGLYCERIN.

Stop An Dask A Doctor

if rash or irritation develops and lasts.

When Using This Product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irriation occurs, only use one topical acne medication at a time. Avoid contact with eyes. Apply only to areas with acne. Do not use on broken skin or large areas of the skin.

Keep Out of 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

Section 51945-4 (51945-4)

Purpose

Acne Treatment

Warnings:

For external use only

Directions:

Clean the skin thoroguhly before applying this product. Cover the entire affected area with a thin layer. Leave on for 10-15 minutes. Rinse skin with warm water. Use 1-2 times a week. Can be applied on pimple as a spot treatment.

Active Ingredient (Active ingredient)

Sulfur 5%

Inactive Ingredients: (Inactive ingredients:)

WATER, KAOLIN, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, NIACINAMIDE, GUM ARABIC, CETYL ALCOHOL, BENTONITE, CETEARYL ALCOHOL, CETEARETH-20, BUTYROSPERMUM PARKII (SHEA) BUTTER, SALICYCLIC ACID, HYDROLYZED ARDENIA FLORIDA EXTRACT, MENTHA PIPERITA (PEPPERMINT) OIL, EUCALYPTUS GLOBULUS LEAF OIL, SALIX NIGRA (WILLOW) BARK EXTRACT, TANACETUM ANNUUM, TOCOPHERYL ACETATE, ALOE BARBADENSIS LEAF JUICE, ALPHA-ARBUTIN, KOJIC ACID, AZELAIC ACID, RETINYL PALMITATE, TOCOPHEROL OIL, VACCINIUM MACOCARPON (CRANBERRY) FRUIT EXTRACT, XANTHAN GUM, MALTODEXTRIN, SODIUM PCA, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, GLUTATHIONE, TARTARIC ACID, CITRIC ACID, PHENOXYETHANOL, ETHYLHEXAYLGLYCERIN.

Stop An Dask A Doctor (Stop an dask a doctor)

if rash or irritation develops and lasts.

When Using This Product (When using this product)

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irriation occurs, only use one topical acne medication at a time. Avoid contact with eyes. Apply only to areas with acne. Do not use on broken skin or large areas of the skin.

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)