DERMAHARMONY ZINC THERAPY- pyrithione zinc liquid 
D3 Development, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Zinc Therapy Cleanser

Drug Facts

Active ingredient

Pyrithione zinc 2%

Purposes

Dandruff, Seborrheic dermatitis

Uses

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

Warnings

For external use only

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

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

Stop use and ask a doctor if condition 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.

Directions

Other information

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?

1-800-827-3730

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

Made in USA from U.S. and imported ingredients

dermaharmony

Zinc Therapy CLEANSER

2% Pyrithione Zinc for Seborrheic Dermatitis & Dandruff

HELPS STOP: FLAKING, REDNESS, IRRITATION, SCALING

4 FL OZ (118 ml)

71819-016 Final

DERMAHARMONY ZINC THERAPY 
pyrithione zinc liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71819-016-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/2021
2NDC:71819-016-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/2021
3NDC:71819-016-641893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/2021
4NDC:71819-016-993785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/2021
5NDC:71819-016-10296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H09/05/2021
Labeler - D3 Development, Inc. (043195877)

Revised: 9/2021
Document Id: cb442483-b734-01a0-e053-2995a90aaff5
Set id: cb442483-b735-01a0-e053-2995a90aaff5
Version: 1
Effective Time: 20210905
 
D3 Development, Inc.