DERMAHARMONY ZINC THERAPY- pyrithione zinc liquid

Dermaharmony Zinc Therapy by

Drug Labeling and Warnings

Dermaharmony Zinc Therapy 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

Pyrithione zinc 2%

PURPOSE

Purposes

Dandruff, Seborrheic dermatitis

INDICATIONS & USAGE

Uses

Controls, reduces, and helps stop the symptoms of dandruff and seborrheic dermatitis.

WARNINGS

Warnings

For external use only

Ask a doctor before use if you haveseborrheic dermatitis that covers a large portion of the body

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

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

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

DOSAGE & ADMINISTRATION

Directions

• Shake before each use
• 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 well

STORAGE AND HANDLING

Other information

• Store at room temperature
• Lot number and expiration date on bottom

INACTIVE INGREDIENT

Inactive ingredients

Water, Lauryl Glucoside, Cocamidopropyl Hydroxysultaine, Sodium Lauroamphoacetate, Distearyl Phthalic Acid Amide, Sodium Chloride, Lauramine Oxide, Melaleuca Alternifolia (Tea Tree) Oil, Soyethyl Morpholinium Ethosulfate, Phenoxyethanol, Aloe Barbadensis Leaf Juice

QUESTIONS

Questions?

1-800-827-3730

SPL UNCLASSIFIED SECTION

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

Made in USA from U.S. and imported ingredients

PRINCIPAL DISPLAY PANEL

dermaharmony

Zinc Therapy CLEANSER

2% Pyrithione Zinc for Seborrheic Dermatitis & Dandruff

HELPS STOP: FLAKING, REDNESS, IRRITATION, SCALING

4 FL OZ (118 ml)

INGREDIENTS AND APPEARANCE

DERMAHARMONY ZINC THERAPY 
pyrithione zinc liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71819-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
SOYETHYL MORPHOLINIUM ETHOSULFATE (UNII: J8C5W5HH18)
DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI)
TEA TREE OIL (UNII: VIF565UC2G)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71819-016-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/05/2021
2	NDC: 71819-016-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/05/2021
3	NDC: 71819-016-64	1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/05/2021
4	NDC: 71819-016-99	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/05/2021
5	NDC: 71819-016-10	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	09/05/2021

Labeler - D3 Development, Inc. (043195877)

Establishment
Name	Address	ID/FEI	Business Operations
Vanguard Soap, LLC.		831404954	manufacture(71819-016)