NDC | 71819-007-04, 71819-007-12, 71819-007-64, 71819-007-99 |
Set ID | 637851c6-ff4a-8bbc-e053-2991aa0a963c |
Category | HUMAN OTC DRUG LABEL |
Packager | D3 Development, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART358H |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
Ask a doctor before use if you have seborrheic dermatitis that covers a large portion of the body.
Close - WHEN USING
When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Close - STOP USE
Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.
Close - KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Close - 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 can be found on the bottom of this container
- INACTIVE INGREDIENT
Inactive ingredients
Water, potassium cocoate, potassium oleate, olive oil, vegetable glycerin, coco glucoside, salt, oatmeal, citric acid
Close - QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
dermaharmony
Zinc Therapy SOAP
2% Pyrithione Zinc for Seborrheic Dermatitis & Anti-Dandruff
MEDICATED NATURAL CASTILE SOAP
4 FL OZ (118 ml)
- INGREDIENTS AND APPEARANCE
ZINC THERAPY
pyrithione zinc liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71819-007 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) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) POTASSIUM COCOATE (UNII: F8U72V8ZXP) GLYCERIN (UNII: PDC6A3C0OX) OATMEAL (UNII: 8PI54V663Y) POTASSIUM OLEATE (UNII: 74WHF607EU) OLIVE OIL (UNII: 6UYK2W1W1E) COCO GLUCOSIDE (UNII: ICS790225B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71819-007-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/23/2018 2 NDC:71819-007-12 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/23/2018 3 NDC:71819-007-64 1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/23/2018 4 NDC:71819-007-99 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/23/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 01/23/2018 Labeler - D3 Development, Inc. (043195877)