DERMAHARMONY 10% SULFUR WITH TEA TREE OIL- sulfur soap

Dermaharmony 10% Sulfur by

Drug Labeling and Warnings

Dermaharmony 10% Sulfur by is a Otc medication manufactured, distributed, or labeled by D3 Development, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Sulfur 10%

PURPOSE

Purpose

Acne medication soap

INDICATIONS & USAGE

Uses

• For the treatment of acne.
• Clears acne blemishes, blackheads, and whiteheads.

WARNINGS

Warnings

For external use only

Do not use on

• broken skin.
• large areas of the skin.

When using this product

• apply only to areas with acne.
• skin irritation and dryness is 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.

Stop use and ask a doctor ifskin irritation occurs or gets worse.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• using warm water, wash affected area for 1-2 minutes, avoiding contact with the eyes.
• rinse thoroughly and pat dry with a clean towel.
• because excessive drying of the skin may occur start with 1 application daily, then gradually increase to 2-3 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.

STORAGE AND HANDLING

Other informationStore at room temperature in a dry place.

INACTIVE INGREDIENT

Inactive ingredients

Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, tea tree (Melaleuca alternifolia) oil, sodium chloride, coconut (Cocos nucifera) fruit extract, palm (Elaeis guineensis) fruit extract, pentasodium penetate

*May contain this ingredient

QUESTIONS

Questions?

1-800-827-3730www.dermaharmony.com

SPL UNCLASSIFIED SECTION

Distributed by: D3 Development, Inc., Portland, ME 04101

Made in USA

PRINCIPAL DISPLAY PANEL

dermaharmony

10% Sulfur SOAP with Tea Tree Oil

For Acne Pimples, Blackheads & Whiteheads

NET WT 4 OZ (113 G)

INGREDIENTS AND APPEARANCE

DERMAHARMONY 10% SULFUR  WITH TEA TREE OIL
sulfur soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71819-015
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
TEA TREE OIL (UNII: VIF565UC2G)
ELAEIS GUINEENSIS FRUIT (UNII: 80T6U6714J)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PALMATE (UNII: S0A6004K3Z)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
SODIUM COCOATE (UNII: R1TQH25F4I)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
COCONUT (UNII: 3RT3536DHY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71819-015-04	113 g in 1 POUCH; Type 0: Not a Combination Product	07/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	07/20/2021

Labeler - D3 Development, Inc. (043195877)

Establishment
Name	Address	ID/FEI	Business Operations
Vanguard Soap, LLC.		831404954	manufacture(71819-015)