Dermaharmony Zinc Therapy: Package Insert and Label Information

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.

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

  • 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

Other information

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

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
(click image for full-size original)
DERMAHARMONY ZINC THERAPY
pyrithione zinc liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71819-016
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC 2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
LAURYL GLUCOSIDE
WATER
COCAMIDOPROPYL HYDROXYSULTAINE
SOYETHYL MORPHOLINIUM ETHOSULFATE
DISTEARYL PHTHALAMIC ACID
TEA TREE OIL
LAURAMINE OXIDE
SODIUM LAUROAMPHOACETATE
ALOE VERA LEAF
PHENOXYETHANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71819-016-04 118 mL in 1 BOTTLE, PLASTIC None
2 NDC:71819-016-12 355 mL in 1 BOTTLE, PLASTIC None
3 NDC:71819-016-64 1893 mL in 1 BOTTLE, PLASTIC None
4 NDC:71819-016-99 3785 mL in 1 BOTTLE, PLASTIC None
5 NDC:71819-016-10 296 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 09/05/2021
Labeler — D3 Development, Inc. (043195877)

Revised: 09/2021 D3 Development, Inc.

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