DERMAHARMONY SULFUR AND SALICYLIC ACID- salicylic acid, sulfur soap

Dermaharmony Sulfur and Salicylic Acid by

Drug Labeling and Warnings

Dermaharmony Sulfur and Salicylic Acid 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 ingredients

Salicylic acid 2%

Sulfur 5%

PURPOSE

Purpose

Dandruff / sebhorreic dermatitis / psoriasis soap

INDICATIONS & USAGE

Uses

​Helps prevent and control recurrence of itching, flaking and irritation associated with dandruff, sebhorreic dermatitis, and psoriasis

WARNINGS

Warnings

For external use only

ASK DOCTOR

Ask a doctor before use if you have a condition that covers a large area of the body.

WHEN USING

When using this product, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION

Directions

• Use on affected areas in place of your regular soap.
• For best results use at least twice a week or as directed by a doctor.
• Work up a lather using warm water and massage into affected areas.
• Rinse.

STORAGE AND HANDLING

Other information

• Store at 59° to 77°F (15° to 25°C)
• Lot number and expiration date are printed on back panel

INACTIVE INGREDIENT

Inactive ingredients

Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, soyethyl morpholinium ethosulfate (soy derived), sodium chloride, pentasodium pentetate

*May contain this ingredient

QUESTIONS

Questions?

1-800-827-3730

www.dermaharmony.com

SPL UNCLASSIFIED SECTION

Distributed by:

D3 Development, Inc., Portland, ME 04101

Made in the USA

PRINCIPAL DISPLAY PANEL

dermaharmony

5% Sulfur & 2% Salicylic Acid SOAP

For Dandruff, Sebhorreic Dermatitis & Psoriasis

NET WT 4 OZ (113 G)

INGREDIENTS AND APPEARANCE

DERMAHARMONY SULFUR AND SALICYLIC ACID 
salicylic acid, sulfur soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71819-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	5 g  in 100 g
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
SODIUM COCOATE (UNII: R1TQH25F4I)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
SODIUM PALMATE (UNII: S0A6004K3Z)
SOYETHYL MORPHOLINIUM ETHOSULFATE (UNII: J8C5W5HH18)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71819-004-04	113 g in 1 CELLO PACK; Type 0: Not a Combination Product	07/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/02/2019

Labeler - D3 Development, Inc. (043195877)