DERMAHARMONY SULFUR AND SALICYLIC ACID- salicylic acid, sulfur liquid

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 ingredient

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 or shampoo.
• 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/expiration date are printed on bottom of this bottle.

INACTIVE INGREDIENT

Inactive ingredients

Water, Potassium Cocoate, Potassium Oleate, Potassium Olivate, Sodium Acrylates / Beheneth-25 Methacrylate Crosspolymers, Pumice, Glycerin, Acrylates Copolymer, Citric Acid

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

Sulfur & Salicylic Acid SOAP

For Dandruff, Sebhorreic Dermatitis & Psoriasis

MEDICATED NATURAL CASTILE SOAP

4 FL OZ (118 ml)

INGREDIENTS AND APPEARANCE

DERMAHARMONY SULFUR AND SALICYLIC ACID 
salicylic acid, sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71819-006
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 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID (UNII: J94PBK7X8S)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
PUMICE (UNII: NT5NN5KL16)
WATER (UNII: 059QF0KO0R)
POTASSIUM COCOATE (UNII: F8U72V8ZXP)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM OLIVATE (UNII: 3H8EO46QKE)
POTASSIUM OLEATE (UNII: 74WHF607EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71819-006-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
2	NDC: 71819-006-10	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
3	NDC: 71819-006-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
4	NDC: 71819-006-64	1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020
5	NDC: 71819-006-99	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	03/27/2020

Labeler - D3 Development, Inc. (043195877)